616 Mdr Jobs - Page 19

Summary The Quality Assurance (QA) Specialist position is responsible for managing to support data management and analysis activities. The role primarily involves transitioning critical data from PDF documents to structured Excel sheets, followed by thorough analysis using Excel or Minitab to support quality monitoring, process improvement, and compliance initiatives. Responsibilities Extract and convert quality-related data from PDF documents into Excel spreadsheets with a high degree of accuracy. Validate the accuracy and integrity of transcribed data to ensure consistency with original sources. Organize, clean, and structure data to facilitate LoTs analysis on quality data and reporting. Conduct statistical analysis using Excel or Minitab to identify trends, variances, or anomalies in quality performance. Generate and maintain dashboards, charts, and summary reports for internal stakeholders. Support root cause analysis and CAPA (Corrective and Preventive Actions) initiatives by providing data insights. Collaborate with cross-functional teams including production, engineering, and compliance to ensure data-driven quality decision-making. Adhere to documentation standards and maintain data confidentiality and traceability. Continuously looking for opportunities to improve data handling and reporting processes. Maintain accurate documentation and ensure data confidentiality. Participate in training and development programs to build quality and data analysis skills. Essential Functions of the Role**: Time management over multiple time zones Must have manual dexterity (use of mouse, keyboard), to type and enter data in the computer as well for preparing presentations Effective communication skills; negotiating, conference calls, video calls, talking, listening Work Experience Requirements Number of Overall Years Necessary: 2-5 Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA, Quality Education Requirements Bachelor's degree in science, engineering, statistics or related discipline Experience with ISO 13485, 21 CFR 820, MDD / MDR, ISO 14971 Exposure to document automation or PDF data extraction tools (e.g., Adobe Acrobat Pro, Tabula, etc.) is an advantage Specialized Skills/Technical Knowledge Strong proficiency in Microsoft Excel (pivot tables, charts, formulas) and working knowledge of Minitab. Experience with data extraction and manipulation from PDFs. Familiarity with quality tools and statistical techniques. Attention to detail and a commitment to data accuracy and quality. Strong organizational, communication, and documentation skills. Mode - Hybrid Location - Gurugram Show more Show less

Description INSLP (Security & Loss Prevention) is hiring an SLP Specialist to support growth of the “SLP MDR Concessions Abuse Program” and help preventing losses via identification of abusive entity. The program is aimed at identifying and eliminating Concessions Abuse while preserving customer trust. The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with INSLP guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. As a part of the SLP MDR Concessions Abuse program, the SLP Specialist is required to deep dive into the Concessions request raised by customer, and conduct end-to-end investigation across customer, DA/network and seller to identify the abusive entity. SLP has outlined frameworks for investigation, and the SLP Specialist is bound to adhere to the investigation guidelines. Along with primarily supporting on Concessions investigations, the SLP Specialist will be required to provide on-ground intel useful in uncovering abuse MOs. In order to ensure network integrity, the SLP Specialist will be required to conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Key job responsibilities Security Operation Implementation and follow-up of Loss Prevention Plan in MDR Concessions Audits and Compliance Conducting SLP audits and implementing SOPs Surprise check and reports at LM (Last Mile) stations Keeping the plans and SOPs updated Periodical check of documentation Adhering to SLAs defined for the SLP MDR Concessions Abuse Program Process Improvement and Loss Prevention Process review, gap analysis and implementation of necessary improvements Weekly, monthly and quarterly assessments Loss prevention reporting Working on feedbacks received from internal and external stakeholders Follow up and completion of CAPA Recommending loss prevention initiatives based on on-ground intel Loss Prevention Analysis and Investigation Work closely with the SLP and CS teams to analyze the loss trends in MDR Concessions Weekly loss trend analysis, identifying defects / abusive entities and working towards loss reduction Conduct investigations by working closely with CS and support functions in SLP and Ops Meeting the weekly investigation targets and submitting investigation reports Sharing RCAs and PTG initiatives on shrink and unmet goals Basic Qualifications An Associate’s Degree or related work experience. 2+ years of experience working with written language data, including experience with annotation, and other forms of data markup. Strong proficiency in English. Candidate must demonstrate excellent writing, reading, and comprehension skills (C2 level in the Common European Framework CEFR scale). Strong understanding of U.S.-based culture, society, and norms. Strong research skills to gather relevant information, understand complex topics, and synthesize multiple resources; understanding of basic academic integrity, i.e. plagiarism. Excellent attention to details and ability to focus for a long period of time. Comfortable with high-school level STEM Ability to effectively write and evaluate diverse subject matter across various domains Ability to adapt writing style to suit various style guidelines and customers. Ability to adapt well to fast-paced environm Preferred Qualifications Loss Prevention experience Investigation/Security related certification Emergency Response / Crisis Management certification Training & Development experience Auditing and security investigations experience Exposure to MNC culture and dynamics Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner. Company - ATSPL - Telangana Job ID: A2982808 Show more Show less

Job Description for Regulatory Affairs: Prepare and submit regulatory documentation for new and existing products. Monitor and interpret global regulatory requirements relevant to physiotherapy and medical equipment. Maintain regulatory compliance throughout the product lifecycle. Interface with regulatory agencies, notified bodies and external consultants. Ensure accurate and timely product registrations in target markets. Maintain up-to-date Device Master Files (DMF) and Technical Documentation. Support clinical evaluation and risk assessment documentation where required. Ensure products comply with applicable regulations, standards and guidelines Manage change notifications, renewals, amendments and post-market surveillance requirements. Support A for audits, CAPAs, internal documentation practices and inspections from regulatory bodies. Provide regulatory guidance to R&D, QA, Marketing during product development and changes. Review and approve labeling, packaging and promotional materials to ensure compliance. Collaborate with external consultants, legal teams or distributors for country-specific compliance. Monitor regulatory changes and industry updates across markets. Participate in external seminars, forums and internal training to build regulatory awareness. Supporting and enabling effective and efficient communication that results in operational excellence. Skills required: Degree in Biomedical Engineering, Pharmacy or related field. 3–6 years of regulatory experience in the medical device industry. Strong knowledge of regulatory frameworks (US FDA, EU MDR, CDSCO, ISO 13485). Experience with regulatory submissions and product registrations. Excellent technical data interpretation skills including problem solving Excellent oral and written communication skills with strong presentation skills Demonstrate subject matter and area expertise Excellent computer skills; Good knowledge of document management systems Excellent written and verbal communication skills Highly proficient with Microsoft Word, PowerPoint and Excel. Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines Job Type: Full-time Pay: ₹40,000.00 - ₹50,000.00 per month Benefits: Health insurance Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Work Location: In person

1. University degree level or equivalent through experience and professional certification. 2. A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession. 3. Extensive and up to date knowledge of Shrink management and Data Analysis. 4. Experience in managing or coordinating security investigations of complex nature. 5. Knowledge of information security processes and systems. 6. Experience in security auditing Job Description: The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with India Security and Loss Prevention guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. Identify the MDR shrink aspects last mile stations, including delivery partners. Identify the potential pilferage opportunities and organized fraud and work closely with the concerned stakeholders to mitigate the causes of losses. Optimum utilization of the resources to ensure and maintain high quality and timely support to Business teams. Conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. 1. Security Operation. Implementation & Follow-up of Loss Prevention Plan in MDR. 2. Audits and Compliance Conducting the SLP audits & implement the SOPs Preparation of Documents for Internal & External Audits Surprise Check and reports 3. Process Improvement & Loss Prevention Program Process Review, Gap analysis & Necessary Improvements Weekly, Monthly and Quarterly Assessment Loss Prevention Reporting feed backs from Internal and External Stakeholders 4. Loss Prevention Analysis and Investigation Weekly loss trend analysis, Identifying the defeats and work of the loss input reduction Conduct Investigation by working closely with stakeholders’ team and support functions in SLP related areas. Meeting the weekly Investigation targets and submission of reports. 1. Loss Prevention Experience 2. Investigation/Security related Certifications. 3. Emergency Response / Crisis Management 4. Training & Development. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

Company overview: TraceLink’s software solutions and Opus Platform help the pharmaceutical industry digitize their supply chain and enable greater compliance, visibility, and decision making. It reduces disruption to the supply of medicines to patients who need them, anywhere in the world. Founded in 2009 with the simple mission of protecting patients, today Tracelink has 8 offices, over 800 employees and more than 1300 customers in over 60 countries around the world. Our expanding product suite continues to protect patients and now also enhances multi-enterprise collaboration through innovative new applications such as MINT. Tracelink is recognized as an industry leader by Gartner and IDC, and for having a great company culture by Comparably. Position Overview TraceLink is looking for experienced Market Development Representatives to join our Pune-based team. As a MDR you will work together with our global Business Management, Commercial Operations, and Sales team members to intensely research companies, qualify and mature TraceLink’s inbound & outbound leads, and diligently engage prospects in order to organize meetings with Sales and Account Managers. Responsibilities Gather market intelligence and deeply research customer and prospect accounts through public and private data sources Qualify and score inbound leads to identify and prioritize key companies & personas for maximum campaign effectiveness Monitor public information sources to augment accounts, leads, and opportunities with data to enhance prospecting effectiveness Develop personalized strategies for using email, social media, and other channels to engage prospects to increase engagement rates Quickly follow up on marketing campaigns to create and maintain account intelligence briefs for Sales and Account Managers to prepare them for prospect and customer meetings Leverage teammates (Managers, and Sales & AMs) to develop targeted lists, call and email strategies, and messaging to drive opportunities and prospecting activities Work with partners including Finance, Marketing & Sales Operations, and Business Management to enrich, cleanse and triage account data Engage with functions such as Business Management, Marketing, and Sales to understand business priorities Document activity in Salesforce and report qualitative and quantitative results on a weekly basis Qualifications 2-5 years experience in Market Development, Business Development, or similar roles Ability to effectively research, qualify, and react to leads and business opportunities BA/BS or equivalent graduation education. Experience with Salesforce.com, Marketo, or similar applications Excellent knowledge of MS Office (Outlook, Word, PowerPoint, and Excel). Precise, professional communication style through both written and verbal channels Professional, empathetic manner capable of managing time and prioritizing tasks effectively with autonomy Proven experience working closely with cross-functional teams Ability to work in a fast-paced international start-up environment Please see the Tracelink Privacy Policy for more information on how Tracelink processes your personal information during the recruitment process and, if applicable based on your location, how you can exercise your privacy rights. If you have questions about this privacy notice or need to contact us in connection with your personal data, including any requests to exercise your legal rights referred to at the end of this notice, please contact Candidate-Privacy@tracelink.com. Show more Show less

Description Job Description: The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with India Security and Loss Prevention guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. Identify the MDR shrink aspects last mile stations, including delivery partners. Identify the potential pilferage opportunities and organized fraud and work closely with the concerned stakeholders to mitigate the causes of losses. Optimum utilization of the resources to ensure and maintain high quality and timely support to Business teams. Conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Security Operation. Implementation & Follow-up of Loss Prevention Plan in MDR. Audits and Compliance Conducting the SLP audits & implement the SOPs Preparation of Documents for Internal & External Audits Surprise Check and reports Process Improvement & Loss Prevention Program Process Review, Gap analysis & Necessary Improvements Weekly, Monthly and Quarterly Assessment Loss Prevention Reporting feed backs from Internal and External Stakeholders Loss Prevention Analysis and Investigation Weekly loss trend analysis, Identifying the defeats and work of the loss input reduction Conduct Investigation by working closely with stakeholders’ team and support functions in SLP related areas. Meeting the weekly Investigation targets and submission of reports. Basic Qualifications University degree level or equivalent through experience and professional certification. A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession. Extensive and up to date knowledge of Shrink management and Data Analysis. Experience in managing or coordinating security investigations of complex nature. Knowledge of information security processes and systems. Experience in security auditing Preferred Qualifications Loss Prevention Experience Investigation/Security related Certifications. Emergency Response / Crisis Management Training & Development. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner. Company - ATSPL - Rajasthan - C74 Job ID: A3001605 Show more Show less

How will you CONTRIBUTE and GROW? This procedure defines the detailed work instructions to be followed during project execution for expediting vendor’s activity to ensure - readiness of the equipment and related documentation for manufacturing, inspection and dispatch within contractual delivery dates. This procedure applies to equipment procured from external suppliers during the project. This document does not apply for the expediting of engineering services, which shall be done directly by the concerned engineering discipline and also for the services required at construction sites which shall be done directly by site construction manager. Develop project specific OM/E execution plan for Order Management / Expediting Monitor documents and information to be received from suppliers (organization chart, progress report, fabrication schedule, overview on the critical material for prefabrication). Compile and issue expediting visit reports as well as minutes of meetings held with supplier. Conduct expediting visits to suppliers with reinforced expediting in case of failing suppliers and raise appropriate alert to the project when delay detected. Proactively monitor all supplier activities from design development, material procurement phase, manufacturing and testing process as well as shipping preparation Review vendor progress reports, fabrication schedules and raise appropriate alert to the project in case of deviations. Interface with suppliers and Inspection department to monitor inspection hold and witness points. Expedite the issuance of the Inspection Release Certificate (IRC). Monitor and address delayed critical vendor documentation from supplier based on document status by Doc. Control, Follow up with the suppliers on open points / punch list, in cooperation with various disciplines. Identify potential areas of concerns or delays with deliveries and initiate appropriate corrective actions. Collecting recovery plan from supplier followed by supporting plan review by AL. Enter tracking data and keep up to date the progress management tool (OM/E Dashboard – manual tables or SAP database / ERP system , based on project requirements including reporting to the client if required) Compile and issue monthly expediting report, following the guidelines of the OM/E procedure. Expeditor will maintain the records for issue and acknowledgment for MDR’s The expeditor shall initiate for PIM / PMM in consultation with inspector and Vendor/Supplier. ___________________ Are you a MATCH? Education: Masters/Bachelor Degree Discipline Engineering Additional contractual / commercial / Supply Chain Management education/ qualification may be an added advantage Experience - 10 - 15 Years Industry - Oil & Gas / Petrochemical / EPC Knowledge inERP / SAP Language: English Our Differences make our Performance At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world. Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Exe Date: Jun 2, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Objective Searching for highly motivated candidate having technical expertise in Biosimilar product analysis. Key Responsibilities: The candidate is expected to develop HPLC based methods for protein and peptide products. The candidate is expected to design and implement integrated strategies, linking appropriate analytical tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on RP-HPLC, SEC-HPLC, CEX-HPLC..etc Responsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable. The candidate is expected to qualify the methods for intended purpose for all pipeline products. Responsible for routine in process sample analysis. Responsible for preparation and review of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. Responsible for managing the regulatory queries. The candidate is expected to draft the technical content for regulatory dossier. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager 2 Date: May 15, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Development & Qualification of multiplex based cytokine release assay and Elispot/ flow cytometry based T cell assays to measure the innate and adaptive Immunogenicity of synthetic peptide products Job Responsibilities: Manage the study sample analysis for pipeline products, preparation of study schedule, design of experiments, trouble shooting, data analysis and review of reports. Isolation of PBMC from whole blood and maintenance of commercial cell lines. Coordinate with internal and external stakeholders for reagent procurement, blood collection, instrument installation and calibration. Statistical analysis of data using software. Preparation/ review of standard operating procedures (SOP), method development reports (MDR), sample analysis report (SAR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. Responsible for the operation and maintenance of the Flow Cytometry, Multiplex, ELISPOT and other instruments and statistical software. Managing of chemicals, consumables & critical reagents inventory. Performing calibration of instruments and equipment. Troubleshooting instrument performance and equipment issues. Draft responses for regulatory queries and facilitate internal and external audits. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Executive Biotechnology Date: May 28, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd The candidate is expected to develop Surface Plasmon Resonance (SPR) based methods to measure the kinetic and equilibrium binding constants for protein and peptide products. Responsible for analytical method qualification for all pipeline products. Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. Analytical similarity assessment of in-house products. Preparation of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. The candidate is responsible for the operation and maintenance of the SPR instruments To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues. Educational Qualification: M.SC./ in Biochemistry / Life Sciences / Biotechnology. Technical/functional Skills: Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins. Experience of biosimilarity assessment of biologics for regulated market is desirable. Experience of analytical development for monoclonal antibodies and peptide is highly desirable. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Job Requirements Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 8-12 Years of experience Minimum 6 years’ experience in the medical device industry Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support) Proficiency in Plastic, Sheetmetal and machined part design Part, sub-system and product level concept Design, Complete Engineering design Good knowledge of manufacturing processes Design for compliance with regulatory standards Regulatory standards knowledge like IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral standards, etc. Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting. Risk management documentation as per ISO 14971 DFMEA, PFMEA and SFMEA document preparation and control Document and change management process in medical device industry using PDM/PLM software. Manage complete system Bill of materials and document support Prototype development and supplier management and detailed DFM reviews. Support for Pilot lot assembly & production support Support for maintenance of Design History file, Device History Record and Device Master Record documents Support for Verification and Validation tests Proficiency in 3D tools like Solid works, Creo, etc. Proficiency in GD&T and tolerance stack up Good experience in packaging & label design as per ISTA/equivalent standards Prototyping, testing & product validation for medical devices Work Experience Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing. Expertise in Change Management process. Experience in Sustenance activities in medical products/ Healthcare business Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR Ability to take initiatives and drive the project to completion. Lead team effectively and work closely with customers Project scheduling and planning Desired Skills Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical components Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions. Proficient use of enabling technology, computer and time management skills. Show more Show less

Job Requirements Seeking a detail-oriented and experienced Technical Writer with a strong background in the medical domain. The candidate will be responsible for creating, editing and managing high quality documentation that meets regulatory and end-user needs. Develop, write and maintain clear and accurate documentation, including user manuals, technical specifications, training materials and regulatory documents. Collaborate with SMEs, product managers, software/ hardware, QA and regulatory teams to gather and validate information. Ensure all documentation complies with applicable medical device regulations and standards (eg: FDA, EU MDR, IEC 62304, IEC 60601 etc ) Maintain version control and documentation libraries using appropriate tools and systems Work Experience 5 to 10 Years of experience in technical writing with medical domain experience. Medical device applicable for FDA. EU MDR regulations. IEC 60601, IEC 62304 applicable devices. Extensive knowledge and experience in creating technical documents like User manuals, Service manual, IFUs (Instructions for Use) Proficient in authoring tools such as MS Word Excellent written and verbal communication skills Ability to collaborate with multiple project teams and work in tight deadlines Show more Show less

Job Requirements Mechanical Design Engineer (BE / Diploma in Mechanical or Equivalent) with 14+ Years of experience Minimum 8 years’ experience in the medical device industry Hands-on experience in all phases of medical device life cycle (NPD, sustenance, post market support) Develop Mechanical architecture for medical devices Proficiency in Plastic, Sheetmetal and machined part design Part, sub-system and product level concept Design, Complete Engineering design Good knowledge of manufacturing processes Design for compliance with regulatory standards Regulatory standards knowledge like IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral standards, etc. Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting. Risk management documentation as per ISO 14971 DFMEA, PFMEA and SFMEA document preparation and control Document and change management process in medical device industry using PDM/PLM software. Experience in Obsolescence management. Manage complete system Bill of materials and document support Design documentation, review critical designs and release for Prototype/Production Prototype development and supplier management and detailed DFM reviews. Support for Pilot lot assembly & production support Support for maintenance of Design History file, Device History Record and Device Master Record documents Support for Verification and Validation tests Experience in leading a team in NPD/ Sustenance projects Proficiency in 3D tools like Solid works, Creo, etc. Proficiency in GD&T and tolerance stack up Good experience in packaging & label design as per ISTA/equivalent standards Prototyping, testing & product validation for medical devices Material selection proficiency. Assess the impact of alternate material and finalization with Supplier. Cost conscious while material & process selection Work Experience Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing. Expertise in Change Management process. Experience in Sustenance activities in medical products/ Healthcare business Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR Ability to take initiatives and drive the project to completion. Lead team effectively and work closely with customers Project scheduling and planning Desired Skills Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical components Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions. Proficient use of enabling technology, computer and time management skills. Show more Show less

Job Description Job Overview: The Principal Electrical Engineer is responsible for interpreting internal or external business issues and recommending best practices. They will be tasked with solving complex Electrical-related problems and will work independently with minimal guidance. The Principal Electrical Engineer may be responsible for leading functional teams or projects and is regarded as a specialist in the field of Electrical. As such, they must have in-depth expertise in Electrical as well as broad knowledge of the Electrical discipline within the Engineering function. Responsibilities Key Tasks and Responsibilities: Become fully familiar with the project scope of work, specifications, schedule, and all inter-discipline requirements; including identifying concerns as early as practicable and taking appropriate initiatives to address the issues. Interpret contractual requirements as they relate to engineering execution Identify changes to scope and promptly raise change notifications, including providing any necessary supporting documentation and estimates. Provide similar support for Variation Orders Interface with all disciplines to develop clash-free designs Interface with other departments to obtain input for Discipline designs and drawings Maintain close coordination with other engineering disciplines, SCM, Planning, Fabrication, Marine, and Project Management teams, as required Document substantive communications (communications that result in significant decisions or assignment of actions) and forward copies to the Discipline Lead Engineer and Discipline Manager. Prepare estimates for bid proposals, including technical query reviews, execution statements, and man-hour estimates, identifying software requirements and any other project-specific requirements. Raise technical queries to obtain missing information, clarify work scope, and maintain preferred McDermott procedures, specifications, standards, practices, and operational requirements Prepare, review, and (as Lead Engineer) approve Discipline engineering design basis, philosophies, and technical specifications Participate in finalizing deliverables lists and deliverables, ensuring compliance with specifications and functional integrity Review project schedule and fabrication schedule in relation to construction sequence, milestones, and engineering scope Attend project kickoff and review meetings, vendor meetings, engineering meetings, and offshore site surveys, as required Provide technical direction and review of Designers producing products related to Electrical Engineering Prepare, review, and (as Lead Engineer) approve design reports and procedures Assist in providing necessary design inputs to other disciplines to enable them in proceeding with their deliverables Assist procurement personnel in procuring Discipline equipment, materials, and services; ensuring that work produced complies with Customer objectives and procedures. Procurement assistance includes preparing, reviewing, and (as Lead Engineer) approving requisitions, evaluating technical quotations and preparing queries, compiling bid tabulations and recommendations, preparing purchase requisitions, and coordinating with Procurement to expedite vendor documents, as directed by the Discipline Lead Engineer Assist in updating weight reports based on receipt of vendor information Review and (as Lead Engineer) approve vendor and subcontractor submittals, checking for compliance with project specifications and providing comments as necessary Review and (as Lead Engineer) approve design verification through single discipline check/interdisciplinary check (IDC) Provide technical support to fabrication queries, including identifying defect/rectification requirements Keep the Discipline Manager and Project Management Team apprised of all activities and concerns, technical, budgetary, and manpower related Assist in providing inputs for actual, planning, and forecasting progress reports including associated productivity Check final subcontractor and vendor data manuals to ensure that all requested data has been received and approved Present issues and problems to Customers in a timely manner and assist the Lead Engineer in negotiating resolution in accordance with project and company requirements Perform (as required) Technical Quality Audit reviews in accordance with MDR Global Procedures Assist Lead Engineer with responses to Customers and other agencies (such as certifying authorities, auditors, third parties, etc.) on their review and approval Capture lessons learned and entered them into MDR's Lessons Learned system Guide less experienced engineers on MDR and Discipline procedures, standards, worksheets, design calculations, software, requisitions, technical bid evaluations, technical queries, etc. Supervise and guide assigned engineers and coordinate with project Lead Designers for Discipline engineering and design deliverable Responsible for the engineering integrity of the assigned work area Monitor costs of own work processes Assist in the maintenance of departmental technical guidelines and standard calculation notes Participate in the development and maintenance of Global Procedures, Software, and Standards May participate in standards development committees or task groups such as API Identify and provide training to staff in specific techniques and proprietary software Provide information on employee performance to the Discipline Manager Assist the Discipline manager in interviewing job applicants Review and (as Lead Engineer) approve material lists, P&ID, etc. for Electrical equipment/systems and services for detailing the scope Update and (as Lead Engineer) approve specifications and data sheets for Electrical and bulk materials Review and (as Lead Engineer) approve Electrical system studies/calculations Prepare, review, and (as Lead Engineer) approve one-line diagrams and schematics diagrams Prepare, review, and (as Lead Engineer) approve electrical equipment building layout drawings Prepare, review, and (as Lead Engineer) approve lighting calculations/illumination study for the platform lighting system Prepare, review, and (as Lead Engineer) approve load lists or update load lists issued by Customer Coordinate and arrange for equipment inspection, FAT Participate in FAT & inspection and preparation & resolution of punch lists on the arrival of skid/material Prepare, review, and (as Lead Engineer) approve spare part lists and preservation reports Review and (as Lead Engineer) approve Pre-commissioning and commissioning index and provide technical assistance on-site during pre-commissioning and start-up as required Review and provide input to secondary cable routing (branch cable trays, channel trays, single tubing, etc.) where detailing is not done Advise fabrication yard of installation locations for small E&I equipment that is not sufficiently detailed in the AFC drawings Prepare, review, and (as Lead Engineer) approve cable drum schedules Identify special tools, equipment, and requirements for commissioning and Hook-up Prepare/review Hook-up installation procedures Coordinate with vendors for installation and pre-comm/commissioning Coordinate work content split between onshore fabrication and installation Review and check the electrical equipment list Participate in the checking and (as Lead Engineer) approval of key discipline deliverables such as: All electrical studies using approved software C&E chart and ESD logic diagrams Specifications, Datasheets, Requisitions, TBEs SLD, Interconnection, and trouble-shooting drawings Hazardous area classification drawings Instrument and F&G detector layout Electrical Load list Lighting calculations & lighting layout Error log reports Participate in HAZOP and SIL Studies Provide E&I input to pre-comm. activities and offshore hook-ups When acting as Lead Engineer, in addition: Act as project-based Discipline point of contact in communications and meetings with Customer counterparts Ensure substantive communications are documented Prepare bids and project's Discipline engineering budget and execution plans, updating as required Identify project staff needs based on knowledge of individual engineer's skill sets and provide requests to the Discipline manager Plan, organize, and assign tasks, responsibilities, and man-hour budgets to the discipline team, and verify tasks are completed within budgets Plan Discipline Level 4 detail deliverable schedule/register compliant with the overall execution plan Prepare working forecasts identifying change management plans, corrective action, and real-time schedules. Provide Discipline inputs for actual, planning, and forecasting progress reports including associated productivity Alert the project team of any deviation from the scope or a need for a change order Monitor KPI measurement results and take corrective action as necessary to improve Discipline performance, including performance at interfaces with others Coordinate with other Discipline Lead Engineers and Designers to ensure timely receipt of necessary design inputs Review and approve requisitions, technical quotation evaluations, and queries, compiled bid tabulations and recommendations, and purchase requisitions; and coordinate with Procurement to expedite vendor documents as required Lead the Discipline team during project audits (internal, Customer, and third-party technical audits) and Design Reviews Review comments from Customers & other agencies on documents and drawings produced by the team and resolve and give guidance on their update and incorporation Assist the Discipline manager in the preparation of quarterly forecasts and manpower planning Anticipate project engineering needs and plan accordingly Coordinate with vendor for discipline managed/procured items Assist the Discipline manager and Project Engineering Manager or Project Manager in the Performance Evaluation of project team members Perform cold eye / SME review for other projects Assume responsibility for schedule, quantity, and quality of project deliverables Ensure quality of design deliverables / physical design / Bulk MTOs through robust checking process Reports to: Project: Project Engineering Manager or Project Manager Functional: Discipline Manager Liaise With: All Engineering disciplines, Fabrication Groups, Safety Dept, Project Management Team, Document Control, Project Planner, Project Cost Controller, QC and Certification Group, Procurement Group, Subcontractors and Vendors, and Customers Qualifications Essential Qualifications and Education: Bachelor’s degree in Engineering or master’s degree 18+ years in oil and gas with major contractors or consultants predominantly performing detail design Detailed knowledge of design techniques and analysis methods, and detailed knowledge of the theory, content, and application of standards, codes, and guidelines as applicable Knowledgeable in project coordination and execution skills Develop communication and presentation skills (e.g., write technical papers, participate in conferences and/or seminars, present design solutions, and/or present topics at "lunch and learns"; etc.) About Us Our ingenuity fuels daily life. Together, we’ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably. For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries. Show more Show less

Head of Quality Assurance & Regulatory Affairs (QA/RA) Job Description As the In-charge of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards. Duties/Responsibilities Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. - To lead in new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. - Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements. - Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements - Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Responsible to improve and implement the QMS for ISO 9001:2008 and ISO 13485:2003, European Medical Device Directive MDD 93/42/EEC Follow-up the Indian GMP regulation and ensure compliance of the technical file according to Indian regulation. Responsible for monitoring of critical processes for site in compliance of operations, Quality Management and regulatory affairs. Point of contact between the responsible countries, HQ and Asia regional office in ensuring processes and local activities meet the respective country's regulatory and legal requirements. Management Representative for the company. To be involved in Management review committee and an Executive Board member. - Drives resolution of issues. Communicates issues, impact and outcomes to the management team. - Responsible for ensuring compliance to the submission standards, procedures and policies in India. Author and refine technical documentation necessary to maintain our current CE Markings and to complete a design dossier suitable for submission for new products. Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc. Train all employees to the QMS, and assess skills, knowledge and QMS application. Perform internal audits to assess the company compliance with our QMS. Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information. Work with our Notified Body to maintain current certifications Qualifications 10 years of QMS experience and demonstrated leadership experience. 10+ years of experience in regulatory affairs and quality assurance in the healthcare industry Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Ability to prioritise and make decisions. Good problem-solving abilities able to identify salient issues, consider alternative solutions and evaluate the most appropriate course of action. Strong organisational and team-working skills including commitment and flexibility. Sound work ethics. Looks beyond boundaries of own job to support others. Education Bachelors degree required in a science, engineering field or related discipline. Masters/MBA is a plus

Responsibilities: Primary Responsibilities: 1. Regulatory Filings and Compliance of regulatory documents: • Coordinating for planning and execution of device regulatory submissions and all other regulatory related activities, globally • Responsible to assist in activities of authoring, review, submission of device related sections of different combination products • Responsible for preparing the response and submission for any agency queries information request on device activities. • Responsible for ISO 13485/ CE certification audit compliance pertaining to regulatory activities and contributes towards post audit management. • Responsible for device related sections in post approval variation submission of different combination products. • Responsible for preparing the technical files and getting NBOp as per article 117 of EU MDR (2017/745) • Ensuring compliance with GSPR as per Annexure I EU MDR (2017/245) • Responsible for activities associated to the devices, in the dossier preparation for biosimilar product under BLA/IND/MAA and perform review, as required. • Coordinating with partners, customers and authorities for dossier finalization, query response and submission as required. • Responsible for device regulatory related SOPs revisions/update as required within the QMS framework. • Responsible for periodic update collation conducted with the purpose of tracking revisions in device regulatory frameworks and guidelines and ensuring cross functional communication for initiating effective implementation wherever appropriate • Regulatory activities including but not limited to: contributing, executing and assisting the team with preparation of medical device CE Marking technical file, registration dossiers for emerging markets, updating device information in drug registration dossier as appropriate to reflect due to deficiency response, post approval changes, etc. • Supporting activities for ensuring GMP compliance. 2. Contribute in preparatory for liaising with – Regulatory Authorities/ Customers for International market 3. Technical Dossier Review: • Process owner and reviewer (as assigned in specific cases) of all technical documents (documents related to development, manufacturing and control of drug substance, excipients, drug product and devices). • Ensuring good documentation practice within the team. 4. Review of deviations, change control and other routine QMS governing activities: • Review and contribute to action items related to change control, deviations, CAPAs and other documents related to medical devices Show more Show less

Job Title: QC Analyst I At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting. Learn about the Danaher Business System which makes everything possible. This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site lead, the Quality Control Analyst is responsible for managing the day today activities quality control function at Cepheid India Private Ltd. Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements. In this role, you will have the opportunity to: Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs). Competent technical staff for supervision the Testing/ analysis of diagnostic reagents & kits. Perform inspections of incoming, in-process and finished products. Performs and calibration and maintenance of lab equipment as per requirements. May perform special projects on analytical and instrument problem solving. Ensure that lab cleanliness and safety standards are maintained. Qualify test methods as part of new product development activities. Serve as a technical liaison between quality control and other departments Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses & Write or revise standard quality control operating procedures. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines. Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions. Review records and documents for completeness and compliance with company policies and procedures. Support for internal audit schedule, NC, CAPA for site. Review production batch records, QC test results and release product. Education and Experience: Master’s degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years’ experience with in Vitro Diagnostics (IVD) is mandate Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable Quality competent technical person approved as per D&C act if any Knowledge and skills: Hands on Experience on IVD product testing. Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS. Must be flexible to work off-shifts and weekends as per production Schedule. Schedule orientated (able to consistently maintains schedules and meet timelines) Strong interpersonal skills, Effective organization and Communication skills are essential. Good skills in English language Knowledge of Microsoft Word and Excel Strong multi-tasking and attention to details skills. It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Able to interpret quality problem and establish practical solutions within a dynamic business environment. Experience in leading continuous improvement efforts, in both quality systems and products. Knowledge of the process of establishing facility QMS certifications. Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable. When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. The EEO posters are available here. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. Show more Show less

The Product Owner is responsible for the definition and delivery of a part of a product from a customer and market requirement point of view - regarding content, prioritization, quality and customer excitement for a given cost and time frame. Responsible for a part of the product through the product life cycle from the definition to the phase-out. Provides the associated development teams with priorities and expertise regarding the product and ensures completeness and consistency of the derived requirements within the part of the product. Responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several development teams. Internal Interactions: Product Line Manager, Product Manager, Project Manager, Quality Manager, Development Team (e.g. Scrum Master, System Analyst, Architect, Developers, Testers), Usability Engineer, other stakeholders (e.g. Business Units), SCM (Enabling) & Customer Service teams, Technical Writers, etc. External Interactions: Customers – Radiologists, Radiology Technicians, Hospital Administrators, IT Administrators etc. What are my tasks? Elicit and collect stakeholder requests Define and prioritize Market Requirements Analyze Market Requirements (e.g. initiate and manage concepts for complex Market Requirements) Derive, prioritize and communicate Software Requirements Create Software Requirement Specifications (i.e. problem part) Coach/support development team's questions and resolve conflict regarding features and requirements Analyze and decide complaints and defects/bugs Achieve commitments with and motivate development teams, assist development teams in attaining maximum effective sustainable pace for development Ensure quality by evaluating results of iterations and either approve/ accept or reject results based on DONEness criteria Support effort estimations of development teams Analyze change request entries and prioritize with other product backlog items Coordinate cross-feature-area development with peers to facilitate prioritized product development Deliver input for project management Support roll-out of the system, presentation, workshops, training for sales and engineering What do I need to know to qualify for this job? Qualification: A Bachelors / master’s degree in engineering and / or MCA or equivalent. Work Experience: 12 to 15 years. Desired Knowledge & Experience: Healthcare market. Product knowhow and customer understanding Sound knowledge of Clinical Workflows and Healthcare IT, especially in the area of Radiology. Healthcare Industry standards like DICOM and IHE Knowledge in Medical Imaging domain Good understanding of software systems categorized as Medical Device Basic understanding of Legal regulations and standards applicable for medical devices, affecting safety aspects(i.e. FDA 21CFR820QSR, MDR, ISO 13485) Exposure to agile methodology Good programming skills & should have worked for most of the time in software programming roles. Thorough experience in Requirements Engineering, Usability Engineering, and feature definition activities. Product Lifecycle Management & Software development cycle experience Experience in CT & MR modalities & medical imaging tool development is an added advantage. What experience do I need to have? Professional: Several years of experience in the medical device/ healthcare industry (e.g. as a Product Owner, System Analyst, Technology Lead, Lead Architect etc.), expertise in clinical and radiological workflows, experience in image processing. Several years of experience in IT product or solution business. Project / Process: Several years of experience in requirements engineering and SW development. Experience in agile development projects, preferably in Product Owner role. Leadership: Experience with managing internationally staffed teams, management and balancing of different stakeholder expectations, management of product definitions. Ideally several years experience in technical leadership role and communicating direction and coaching others. Intercultural: Experience with international/ intercultural teams, conduction of workshops with international development partners and customers. What else do I need to be strong at? Self driven and takes Initiatives Decision making skills Result orientation Self motivated and provides motivation and inspiration to the team Strong Analytical and Problem-Solving Skills. Strong team player and networking skills Strong written and oral communication skills. Strong interpersonal skills Strong customer focus Show more Show less

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Quality engineer to support PSUR activities for NV OU Careers that Change Lives As a Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. A Day in the Life Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Must Have Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills including plan / report development. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR. Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis. Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on EU MDR. Previous experience working in a cross-functional team environment. Hands-on experience on Risk Management, Design Controls for Medical Devices. Participate when appropriate in audits. Experience in collaborating with regulatory affairs teams for submission of safety reports. Minimum Qualification B E or B.Tech in Mechanical/Biomedical Engineering Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience Key Technical Competencies Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here Show more Show less

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Vice President - Cyber Security Operations Job Statement: NopalCyber makes cybersecurity manageable, affordable, reliable, and powerful for companies that need to be resilient and compliant. Managed extended detection and response (MXDR), attack surface management (ASM), breach and attack simulation (BAS), and advisory services fortify your cybersecurity across both offense and defense. AI-driven intelligence in our Nopal360° platform, our NopalGo mobile app, and our proprietary Cyber Intelligence Quotient (CIQ) lets anyone quantify, track, and visualize their cybersecurity posture in real-time. Our service packages, which are each tailored to a client’s needs and budget, and external threat analysis, which provides critical intelligence, help to democratize cybersecurity by making enterprise-grade defenses and security operations available to organizations of all sizes. NopalCyber lowers the barrier to entry while raising the bar for security and service. We are looking for a proven, high energy, results oriented Cybersecurity Operations Leader, where you will be a key advisor for our clients, analyzing business requirements to design and implement ideal security solutions for their needs. As an established SecOps Leader, you will span operational, tactical, and strategic levels as well as tasks that tackle difficult problems that businesses are facing when building out and improving their security posture. This is an opportunity for you to showcase your strong communication skills and experience in SOC operations, security governance & advisory, security risk management, security architecture, and cyber incident response programs. Job responsibilities: Service Delivery Management: Oversee the end-to-end delivery of Managed XDR, Attack Surface Reduction, and Advisory services to clients, ensuring high-quality outcomes and client satisfaction. SOC Operations Leadership: Lead and manage Security Operations Center (SOC) operations, ensuring effective monitoring, incident management, and response processes are in place. Incident & Escalation Management: Take responsibility for escalations arising from security event monitoring, incident management, and response. Ensure timely resolution and process improvements. SLA & Process Compliance: Ensure that service level agreements (SLAs) are met, while also driving process adherence, continuous improvements, and operational excellence. Governance & Metrics: Establish and refine operational foundations, defining key metrics and KPIs to drive governance, quality, and efficiency. Influence operational change to improve performance. Threat Management & Detection: Lead efforts in threat management, modeling, and hunting. Identify threat vectors and develop use cases and detection rules to enhance security monitoring capabilities. Team Training & Development: Ensure that the team’s skill development and training needs are adequately addressed to maintain cutting-edge security expertise. Cybersecurity Maturity & Resilience: Assist clients in identifying potential threats, vulnerabilities, and deficiencies, advising on measures to enhance their cybersecurity maturity and resilience. Solution Design & Communication: Evaluate client needs, create tailored security solutions, and effectively communicate the value proposition of complex security concepts to both technical and non-technical stakeholders. Security Assessments: Plan and execute IT security assessments of on-premise/cloud IT assets. Understand organizational objectives, policies, and regulations to identify risk areas and prepare comprehensive review programs. Stakeholder Communication: Possess strong communication skills to engage with senior management, board members, technical teams, and key client stakeholders to convey complex security concepts effectively. Sales & Proposal Support: Contribute to sales pursuits, proposals, and the development of security practice eminence. Drive business growth through strategic client relationships. Project Delivery: Lead and deliver complex security projects in a fast-paced, team-driven environment. Knowledge Sharing & Collaboration: Foster a collaborative environment by promoting and participating in forums that enhance the firm’s collective knowledge and assist clients with complex challenges. Enterprise Security Leadership: Provide leadership and strategic direction to the organization’s information security initiatives. Cybersecurity Strategy & Technology Update: Regularly update and refine the cybersecurity strategy to incorporate new technologies and emerging threat information. Client Relationship Management: Establish and maintain strong client relationships to further expand the service portfolio and ensure long-term client success. Job specifications: 1. Qualification: A bachelor’s degree in a related field (e.g., Computer Science, Cybersecurity, or Information Technology) and a minimum of 15 years of relevant work experience. Certifications Certified Information Systems Security Professional (CISSP) or Certified Information Systems Auditor (CISA). Cloud security certifications from major Cloud Service Providers (AWS Certified Solutions Architect, Microsoft Azure Architect, Google Cloud Architect), or Certified Cloud Security Professional (CCSP) / Certificate of Cloud Security Knowledge (CCSK). 2. Desired Skills: Desired Skills & Experience : SOC Expertise: Strong understanding of SOC operations, design, and management. Experience with domain administration, network architecture, and change control procedures. Risk Management Knowledge: Familiarity with IT risk management standards and frameworks, including ISO 31000, NIST Cybersecurity Framework, ISO 27001/27002, GDPR, PCI DSS, SOC 1/SOC 2, COBIT, and HITRUST. Networking & Security Technologies: Knowledge of networking (TCP/IP, OSI model), operating systems (Windows, UNIX, mainframe), security technologies (firewalls, IDS/IPS), and programming languages (C, Java, Perl, Shell). Threat Landscape Awareness: In-depth understanding of cyber-attacks, threat vectors, risk management, and incident response. Security Solutions Proficiency: Hands-on experience with MDR, EDR, XDR, SIEM, Vulnerability Management, IDS/IPS, NTA, UEBA, DLP, and other security technologies. Penetration Testing Tools: Familiarity with penetration testing and application security tools (Kali Linux, Metasploit, Burp Suite, Nessus, NMAP). Security Frameworks & Methodologies: Understanding of OWASP, the MITRE Attack Framework, Cyber Kill Chain, and the SDLC (Software Development Lifecycle). Cloud Security Expertise: Advanced knowledge of cloud security practices and implementations. Vendor/Partner & Client Management: Strong experience in vendor/partner management, client management, and the ability to lead client relationships effectively. Offerings Development: Ability to research and develop innovative security risk-based offerings that meet client needs. Shaping Client Expectations: Expertise in managing and shaping client expectations throughout engagement cycles. #CybersecurityLeadership #VPOfOperations #SecurityOperations #CyberOpsLeadership #OperationsLeadership #CybersecurityVP #SecurityOps #CybersecurityExec #TechOperations #InfoSecLeadership #VPJobs #LeadershipHiring #CybersecurityCareers #OperationsExcellence #SecurityLeadershipRoles #HyderabadJobs #HyderabadHiring #HyderabadCareers #HyderabadTech #HyderabadVP #HyderabadOperations Show more Show less

At Armor, we are committed to making a meaningful difference in securing cyberspace. Our vision is to be the trusted protector and de facto standard that cloud-centric customers entrust with their risk. We strive to continuously evolve to be the best partner of choice, breaking norms and tirelessly innovating to stay ahead of evolving cyber threats and reshaping how we deliver customer outcomes. We are passionate about making a positive impact in the world, and we’re looking for a highly skilled and experienced talent to join our dynamic team. Armor has unique offerings to the market so customers can a) understand their risk b) leverage Armor to co-manage their risk or c) completely outsource their risk to Armor. Learn more at: https://www.armor.com Summary We are seeking a dedicated Technical Support Engineer L2 to join our cybersecurity Support team. As the first point of contact for our global customers using our Managed Detection and Response (MDR) solutions, you will play a crucial role in ensuring customer satisfaction while maintaining the security and functionality of their systems. Essential Duties and Responsibilities (Additional duties may be assigned as required) Provide technical support to global customers for our MDR platform and related cybersecurity products Monitor systems and network health, generating usage reports and tracking potential security issues Diagnose and troubleshoot basic software problems related to our MDR solutions Manage customer incidents using our ticketing system, ensuring timely resolution according to service level agreements Document incidents, solutions, and maintain accurate records for future reference Assist with basic configuration and deployment of MDR sensors, agents, and monitoring tools Identifying potential problems from Microsoft Sentinel / MS Azure / MS Defender logs Participate in 24x7 support rotation to ensure round-the-clock monitoring and incident response Communicate effectively with customers to understand their needs and provide clear technical guidance Required Skills Bachelor's degree in computer science, Information Technology, Cybersecurity or related field (or equivalent experience) 5+ years of experience in technical support, IT Support role, or cybersecurity operations Rudimentary understanding of intrusion detection, firewall operations, and other general security practices. Create VM templates Add/modify/delete disks through VCD Respond to VMWare host and system alerts Intermediate level of networking expertise with understanding of networking fundamentals and well-known protocols/services including GRE, TCP/IP, V-LAN. Proficiency in Windows Server environments and Linux distributions commonly used in enterprise settings Knowledge of managed detection and response (MDR) technologies is a plus Excellent problem-solving skills and keen ability to diagnose and troubleshoot technical issues. Well-spoken and articulate with an attention to detail with excellent writing abilities. Experience with ticketing systems and ITIL methodologies preferred Ability to work in a fast-paced environment and handle multiple priorities simultaneously Willingness to learn new technologies WHY ARMOR Join Armor if you want to be part of a company that is redefining cybersecurity. Here, you will have the opportunity to shape the future, disrupt the status quo, and be a part of a team that celebrates energy, passion, and fresh thinking. We are not looking for someone who simply fills a role – we want talent who will help us write the next chapter of our growth story. Armor Core Values Commitment to Growth: A growth mindset that encourages continuous learning and improvement with adaptability in the face of challenges. Integrity Always: Sustain trust through transparency + honesty in all actions and interactions regardless of circumstances. Empathy In Action: Active understanding, compassion and support to the needs of others through genuine connection. Immediate Impact: Taking initiative with swift, informed actions to deliver positive outcomes. Follow-Through: Dedication to delivering finished results with attention to quality and detail to achieve the desired outcomes. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually low to moderate. The work environment can be either in an office setting or remotely from anywhere. Equal opportunity employer - it is the policy of the company to comply with all employment laws and to afford equal employment opportunity to individuals in all aspects of employment, including in selection for job opportunities, without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other consideration protected by federal, state or local laws. Show more Show less

Prepare, review, and file global premarket documents, collaborate with teams, develop regulatory strategies, and ensure compliance with India, US FDA, and EU regulations for medical devices or pharmaceuticals.

Job Description Job Overview: The Principal Auditor is primarily responsible for guiding the financial, operational, business process or compliance audit towards successful completion at McDermott across the globe. The Principal Auditor effectively interfaces with various levels of management and develops relationships that further the organizational goals. The Principal Auditor should demonstrate high energy, be flexible and innovative and motivated to work in a fast paced and challenging environment that continues to evolve. The position in an individual contributor and reports to Senior Manager, Audit. The Principal Auditor position does not have formal supervisory responsibility for the staff auditors but supervision of staff on engagement is a major component of this position. Responsibilities Key Tasks and Responsibilities: Participate in the annual risk assessment exercise to identify audit plans for the year Plan and execute Finance and Operational process audits and project audits. Project manage SOX/ICFR controls allocated to completion. Ability to handle multiple assignments simultaneously is required Identify opportunities for the use of data analytics within the testing (audits and control testing) assigned Determine, or assist in determining, the objective, scope, and general plan of the assigned audit. Prepare customizable audit programs that identify risks, controls, and audit procedures for each application utilized by the company. Express ideas for ways to improve audit testing, and to help develop automated tests and/or programs that will enhance internal controls Interact effectively with various levels of Management, including Corporate managers, Department managers, and Line managers Prepare formal audit reports of critical findings to be distributed to executive management Demonstrate the ability to document information and findings to support the audit testing and as per IIA and MDR documentation standards Actively contributes to the continuous improvement process of the department’s own internal practices Evaluate the corrective actions performed by the management for its adequacy and effectiveness Be able to provide consulting services to various stakeholders within the company, including guidance around the development, or revision, of Company policies and procedures Perform other responsibilities assigned by Audit Management Keep abreast of current developments in auditing, accounting, IT, fraud, other emerging issues and the oil and gas services industry which may impact the audit process Ability to travel domestically and international (30% to 40%) Qualifications Essential Qualifications and Education: Requires an undergraduate degree from an accredited college or university, either in Accounting and Finance or Engineering If from Finance background, CA, ACCA, CPA or CIA is a must. Other relevant audit qualification such as CISA or CFE would be good to have. Post qualification experience of 8+ years in Finance and operational auditing in multinational companies and/or big 4 accounting firms is a must If from Engineering background, BE is a must. Post graduation in Engineering/Construction Management or PMP would be good to have. Post qualification experience of 8+ years in Project Controls, Operations, Engineering or Consulting in multinational companies and/or big 4 accounting firms is a must Experience in working for Oil & Gas EPC or a contracting company is preferred. International experience is a plus Must work independently with minimal supervision. Demonstrated skills in leading complex audits and in supervising auditors on audit engagements Excellent report writing and verbal communication/presentation skills is a must. Advanced knowledge of excel. Experience with data analytics/visualization tools is required Prior experience with audit software such as AuditBoard About Us Our ingenuity fuels daily life. Together, we’ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably. For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries. Show more Show less

Job Description Working closely with the Global Regulatory Affairs team, you'll be responsible for planning, scheduling, and managing the preparation and submission of regulatory applications to local authorities, including support for EU MDR submissions and approvals. Ensure all marketed devices secure and maintain necessary regulatory approvals, managing registration processes according to both regulatory guidelines and internal company procedures. Proactively maintain an up-to-date project tracker, ensuring all information is current and accurate. Collaboration with the Business Manager and Dealers is crucial to identify and mitigate potential supply chain risks Completes other regulatory activities as assigned by Department Head. Job Requirements Critical Skills Graduate / Postgraduate preferably in Life Sciences or equivalent. 3-5 years Industry Experience in Regulatory Affairs, preferably in medical devices. Knowledge and competency in application of Local regulations D&C Act and Rules, MDR 2017 Good spoken and written of English language. Proficient in the use of MS Word, Excel and PowerPoint Other desired skills: Able to work independently and possess great sense of responsibility, accountability and Highly motivated to take ownership, adaptable to change, and receptive to innovative approaches. Proficient in the use of MS Word, Excel and PowerPoint. Fostering collaboration with key stakeholders. Possesses strong project management skills. Good working attitude. Critical thinking and problem-solving. Strong communication skills. Operating Company Kerr Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Show more Show less