130 Iso 13485 Jobs - Page 5

A Day in the Life In this role, this role will partner with Quality System team members to generate, analyze, communicate, and follow up with stakeholders to actions related to standard reports for the following QMS processes: -Periodic Review of QMS procedures -Training coming due and/or overdue notifications -Quality Data Analysis (QDA) In addition, this role will assist in the retrieval, review, and archival of Allograft Tissue Tracing Records. Responsibilities may include the following and other duties may be assigned: Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office across the following CST QMS entities: o Boxborough o Caesarea o Fort Worth CSF o Fort Worth MPSS o Lafayette o Memphis Pyramid o Memphis SGT Generates and analyzes standard reports (e.g., Periodic Review, Training and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs Communicates coming due and/or overdue notifications for Training and Periodic Reviews to affected personnel, their management, and Quality leadership Coordinates with internal stakeholders to implement corrections to Agile MAP with regards to Document and Process Owners Coordinates with internal stakeholders to implement corrections to Cornerstone with regards to removal of unnecessary trainings Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP Required Knowledge and Experience Bachelor degree; Engineering or Science degrees preferred 3+ years quality assurance experience in medical or pharmaceutical industry Familiarity with medical device Quality Management System requirements (e.g., US 21 CFR Part 820, ISO 13485:2016, Regulation (EU) 2017/745) Experience running data queries and reports in software applications Strong verbal and written communication skills and ability to work in a team oriented environment Agile PLM knowledge/experience Ability to work independently once trained Ability to be proactive and lead initiatives Ability to multitask. 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

Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits

Experienced Candidates in QA as per ISO 13485 review batch records, handle deviations, CAPA, and audits; support validations; write and maintain SOPs; coordinate with cross-functional teams, documentation, and Compliance with regulatory standards. Required Candidate profile Graduate / Post Graduate in biotechnology / bio medical / Microbiology / Chemistry with strong hands on experience in QA operations in any Pharma or medical devices company.

Objectives of this role Design and develop hardware products, including circuit boards, components, and systems, while adhering to industry standards and best practices. Generate and maintain hardware design, testing, and quality control documentation. Participate in design reviews, risk assessments, and product validation activities to ensure compliance with regulations. Collaborate with cross-functional teams, including design, development and customer support, to provide feedback and input on product design, performance optimisation, and manufacturability. Your tasks Conduct thorough testing and validation of hardware products to ensure compliance with specifications, requirements and quality standards. Perform root cause analysis and troubleshooting of hardware defects and implement preventive measures for malfunctions to minimise future occurrences. Stay up to date with the latest advancements in hardware testing methodologies and apply them to improve the overall quality of our products. Required skills and qualifications Bachelors degree in Electrical Engineering, Computer Engineering, or a related field. 5+ years of demonstrable experience as a computer hardware engineer. Strong knowledge of hardware design principles, testing tools, equipment, and techniques (mainly PCB designing). Excellent analytical and problem-solving skills with an eye for detail and precision. Ability to work independently and manage multiple tasks simultaneously. Preferred skills and qualifications Proficiency in programming languages, like C/C++ and/or Verilog/VHDL. Familiar with industry regulations in India, like ISO 9001, ISO 13485, BIS and RoHS. Knowledge of hardware regulatory requirements, such as FCC and CE. Strong communication, teamwork, and project management skills.

Work Flexibility: Hybrid What you will do: Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery. Ensure quality of process and product as defined in the appropriate operation and material specifications. Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings. Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches. Complete capability studies for in process inspection and generate subsequent Inspection documentation. Conduct MSA studies for new products and new processes. Provide training for manufacturing team members. Who we want: Minimum Requirements: Bachelor s degree (B.E.) in Mechanical or related engineering discipline required. 3+ years of work experience required ; Analytical problem solvers; Dedicated achievers and Collaborative partners Preferred Qualifications: Good knowledge of manufacturing processes, materials, product, and process design Project Management experience Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing. Experience in an FDA regulated or ISO 13485 regulated industry- highly preferred. Good understanding of Design for Manufacturing (DFM) related statistical tools and validation/verification technique Travel Percentage: None

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India. Responsibilities: Support the Quality Systems Manager in the management of AliveCor s QMS Maintain AliveCor s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation. Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records. Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies . Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks) Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures. Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure. Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards. Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance. Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed Requirements: Bachelor s degree in Science or Engineering 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.). Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus Excellent organisational skills along with strong attention to detail Ability to work both independently and collaboratively with small, cross-functional teams Highly proficient with Microsoft Office Suite and Adobe Acrobat Perks and benefits: We strive to make your life outside work as smooth as possible while youre at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements. Responsibilities: Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities. Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs. Train and educate key functional partners and management on combination product requirements, standards and regulations Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories. Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging. Provide independent design review for other programs Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection NOTE: This role may require working in shifts or extended hours within the same shift What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Quality experience OR Bachelor s degree and 6 to 8 years of Quality experience OR Diploma and 10 to 12 years of Quality experience Preferred Qualifications: 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus) Bachelor s Degree in a Science Field Ability to oversee multiple medium complexity projects simultaneously Working knowledge of quality engineering and/or mechanical engineering Familiar with final products including applicable guidance, regulations and standards (e. g. , MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211) Prior experience working as part of a combination product launch team Able to successfully manage workload to meet timelines Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving decision making by using Decision, Advice and Inform (DAI) principles Understanding of industry requirements/expectations of a Quality Management System (QMS) Understanding of the applicable manufacturing/testing processes (i. e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations Comfortable with both drug and device terminology Ability to travel +/- 15-20% of time to domestic and international Amgen sites What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com .

A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards ESSENTIAL DUTIES AND RESPONSIBILITIES Technology Support. Participate in Sprint planning. Familiarity and project scope and timelines. Understanding overall feature requirements, test automation framework and developing automation scripts Work closely with system and software Accountable for developing document artifacts as per QMS process. Make sure the testing protocol covers the requirements Traceability analysis to make sure no requirements left uncovered. Automation - work with system and software to define the automation protocols Proactively identify technical limitations and roadblocks if any bring to the table for discussion and suggest solutions. Understand the technological and VV challenge. Understand the details as required. PRINCIPAL WORKING RELATIONSHIPS Reports to the Engineering Manager Interface with VV Lead Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users. EXPERIENCE 5-7 years of software testing experience (preferably medical device) including writing tests protocols and execution At least one year of Test automation experience is added advantage KNOWLEDGE, SKILL, AND ABILITY Experience with both manual testing, Analyzing the requirements and deriving test cases as per quality procedure Identify the ay gaps in requirements or resolve ambiguity in requirements working with the SMEs. Experience working on Ubuntu/Linux and/or Windows Applications. OS, Application installation, configuration, preparing the test data. Experience with Requirements Management tools, configuration management tools. Experience with modern software testing tools and methods, including validation of object-oriented systems. Experience in scripting/ programming languages like Python, JavaScript. Knowledge of object-oriented programming concepts, analytical and logical thinking skills. Good written and oral communication skills to effectively update status, risks, dependencies. Organizational skills essential Self-learning capabilities Good communication and interpersonal skills Collaborate with developers, engineering teams Good team player Good to Have: Experience in regulatory industry in an added advantage Familiarity with FDA regulations and recommended practices, especially regarding software. Familiarity with ISO 13485, ISO 14971, IEC 62304 and other relevant industry standards EDUCATION Required: - B.E or B.Tech in Computer Sciences, Electronics or Electrical Engineer. Preferred: - M.E or M.Tech in Computer Sciences, Electronics or Electrical Engineer. Benefits Compensation 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 RD 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

A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards ESSENTIAL DUTIES AND RESPONSIBILITIES Technology Support. Participate in Sprint planning. Familiarity and project scope and timelines. Understanding overall feature requirements, test automation framework and developing automation scripts Work closely with system and software Accountable for developing document artifacts as per QMS process. Make sure the testing protocol covers the requirements Traceability analysis to make sure no requirements left uncovered. Automation - work with system and software to define the automation protocols Proactively identify technical limitations and roadblocks if any bring to the table for discussion and suggest solutions. Understand the technological and VV challenge. Understand the details as required. PRINCIPAL WORKING RELATIONSHIPS Reports to the Engineering Manager Interface with VV Lead Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users. EXPERIENCE 5-7 years of software testing experience (preferably medical device) including writing tests protocols and execution At least one year of Test automation experience is added advantage KNOWLEDGE, SKILL, AND ABILITY Experience with both manual testing, Analyzing the requirements and deriving test cases as per quality procedure Identify the ay gaps in requirements or resolve ambiguity in requirements working with the SMEs. Experience working on Ubuntu/Linux and/or Windows Applications. OS, Application installation, configuration, preparing the test data. Experience with Requirements Management tools, configuration management tools. Experience with modern software testing tools and methods, including validation of object-oriented systems. Experience in scripting/ programming languages like Python, JavaScript. Knowledge of object-oriented programming concepts, analytical and logical thinking skills. Good written and oral communication skills to effectively update status, risks, dependencies. Organizational skills essential Self-learning capabilities Good communication and interpersonal skills Collaborate with developers, engineering teams Good team player Good to Have: Experience in regulatory industry in an added advantage Familiarity with FDA regulations and recommended practices, especially regarding software. Familiarity with ISO 13485, ISO 14971, IEC 62304 and other relevant industry standards EDUCATION Required: - B.E or B.Tech in Computer Sciences, Electronics or Electrical Engineer. Preferred: - M.E or M.Tech in Computer Sciences, Electronics or Electrical Engineer. Benefits Compensation 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 RD 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

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

Role & responsibilities Manufacturing Drawing Preparation Create 2D manufacturing drawings and 3D models of mechanical components and assemblies. Generate: Part drawings with all required views, sections, and dimensions Assembly drawings with ballooning, BOM integration, and exploded views Fabrication drawings for sheet metal, welded structures, machined components, and plastic parts Apply appropriate Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 or ISO standards. Define tolerances , surface finish , material specifications , welding symbols , and heat treatment notes . Incorporate machining allowances , fits , and limits for manufacturing feasibility. CAD & Drafting Tools Use CAD software such as AutoCAD & SolidWorks for design and detailing. Work with 3D assemblies and extract drawing views, sections, and details as per drawing standards. Manage CAD files and revisions. Drawing Review & Updates Revise drawings based on feedback from engineers, production teams, and design changes. Ensure drawing clarity, completeness, and compliance with internal and industry standards. Support Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews. Documentation & Control Maintain structured drawing repositories with proper naming conventions, revision history, and change tracking. Support document control and release processes through QMS or PLM systems. Preferred candidate profile

We are seeking a PMS and Complaint Analyst with 4 to 6 years of expertise in ISO13485, ISO14971, ISO 62304 (Plus) MDR and EUMDR requirements will be a plus. Requirements: Experience in Complaint handling and PMS for Medical products. In-depth knowledge of Software product development lifecycle. Hands on with complaint management tools such as track wise Is plus. Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers and Manufacturing personnel to facilitate the complaint handling process globally Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint. Initiate complaint in process and applicable tool. Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint. Communicate with customers, call center reps and FSEs to gather more data on complaints as needed. Assess if the Risk assessment is covering the hazard in the complaint. Complete all needed records in a timely and accurate manner Confirm complaint condition and determine corrective action including CAPA as needed. Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed. Evaluate, investigate and resolve complaints. Completes the initial assessment of reportability and escalates to manager to determine action when necessary. Analyzes complaint data, gathers additional data as needed and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects and safety evaluations and resolves complaints. #LI-BL2 #LI-Hybrid

What you will do: Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience Hands on experience of Complaint handling and product investigations process.Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Hands on experience of Risk Management process as per ISO 14971 Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Preferred skilla: Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Travel Percentage: 20%

What you will do Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience. Hands on experience of PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Preferred Skills: Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have). Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Travel Percentage: None

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. COntact Person --Divya /Joy /Jenifer **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years in the Medical domain - **Location:** Hyderabad - **Education:** B.E./B. Tech (Mechanical) - Immediate joiners & 30 days' notice period required **Job Description:** Managing customer complaints related to medical devices, ensuring regulatory compliance and operational efficiency. **Roles and Responsibilities:** - Thorough evaluation and investigation of complaints - Effective collaboration with cross-functional teams - Maintenance of regulatory compliance standards - Detailed reporting and clear communication **Skills Required:** - Freshers to 1 year experience in Medical Devices complaints handling or PMS - Knowledge of global medical device regulations - Strong mechanical problem analysis skills - Excellent written and verbal communication abilities **Interested candidates** can attend the interview and consider this as a call letter. hashtag#apply : https://lnkd.in/gtSxtBBn **Contact Person:** Divya sri (mandru.divyasri@hcltech.com) / Joy /Jenifer **Important Guidelines:** - Only Btech Mechanical candidates are eligible for this Mega drive - Candidates should have all the marks sheet . -

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years in the Medical domain - **Location:** Hyderabad - **Education:** B.E./B. Tech (Mechanical) - Immediate joiners & 30 days' notice period required **Job Description:** Managing customer complaints related to medical devices, ensuring regulatory compliance and operational efficiency. **Roles and Responsibilities:** - Thorough evaluation and investigation of complaints - Effective collaboration with cross-functional teams - Maintenance of regulatory compliance standards - Detailed reporting and clear communication **Skills Required:** - Freshers to 1 year experience in Medical Devices complaints handling or PMS - Knowledge of global medical device regulations - Strong mechanical problem analysis skills - Excellent written and verbal communication abilities **Interested candidates** can attend the interview and consider this as a call letter. hashtag#apply : https://lnkd.in/gtSxtBBn **Contact Person:** Divya sri (mandru.divyasri@hcltech.com) / Joy /Jenifer **Important Guidelines:** - Only Btech Mechanical candidates are eligible for this Mega drive - Candidates should have all the marks sheet . -

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and corrective/preventive action (CAPA) for quality issues and non-conformities. Liaise with production, QA, and R&D teams to address quality-related challenges. Monitor and analyze data from incoming raw materials, in-process controls, and finished goods. Maintain proper documentation and assist in internal/external audits. Qualifications & Skills Bachelor's degree in Engineering (preferably in Biomedical, Mechanical, or Industrial Engineering). 25 years of experience in a QC role within the medical device or pharmaceutical industry. Strong knowledge of ISO 13485, QMS, GMP, and applicable regulatory standards. Hands-on experience with measurement tools (e.g., Vernier calipers, micrometers, leak testers). Proficiency in documentation and data analysis. Familiarity with cleanroom protocols and sterilization validation is a plus.

1. Experience in manufacturing operations 2. 6+ years experience in a supervisory capacity and leadership roles 3. Bachelors degree in production management, Engineering, or a related field. 4. Excellent project management skills 5. Experience in creating procedures and monitoring product servicing activities 6. Experience in production and quality control as per ISO 13485 7. Decent understanding of medical device manufacturing processes 8. Proven track record of successfully training employees in productivity and safety 9. Ability to coach and mentor employees on a one-on-one basis as well as a group 10. Knowledge of project management principles and practices 11. Knowledge of business and management principles and practices

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management Skills : - Cypress, API automation, Appium, TestNG, Jenkins, JIRA, JAMA, GIT, SaaS applications, HIPAA, ISO 13485, IEC 62304, software testing, medical device testing, test automation, defect tracking, agile methodology

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS applications Proficiency in developing API, Web, and Mobile (iOS and Android) test automation using tools like Cypress, API automation, Appium, TestNG, and Jenkins Familiarity with agile development methodologies and tools like JAMA, JIRA, and GIT Strong knowledge of HIPAA, ISO13485, and IEC62304 is highly desired Roles and Responsibilities: Collaborate with cross-functional teams to define use cases, write test plans, and execute test cases for medical devices Analyze product requirements and design appropriate test strategies and verification plans Ensure compliance with regulatory standards in coordination with the regulatory team Develop and implement automated test solutions to enhance product quality, robustness, compliance, and user satisfaction Identify, document, and track defects using issue tracking software (JIRA) Continuously improve testing processes and contribute to product lifecycle management

Role & responsibilities Job Summary : We are seeking an experienced and highly motivated IVDR Technical Manager to join our team. In this role, you will lead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for in-vitro devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners. The ideal candidate will have a strong background in regulatory affairs, technical documentation, and quality management systems, with the ability to manage the technical aspects of IVDR compliance for a diverse portfolio of IVD products. Key Responsibilities : Competence Management Manage the competence process for all technical roles as per the accreditation and regulatory requirements in DNVs procedures. This includes the initial qualification as well as maintaining them. Cross-team Collaboration Work closely with the sales and planning functions, as well as other key internal stakeholders to enhance the operational cooperation and interaction within the IVDR services delivery and promote best practice sharing. Ensure to provide or address technical support when needed to the same functions. Proactively identify and recommend process improvements. Compliance and Regulatory Updates Work with cross-functional teams to ensure all stakeholders are informed of IVDR requirements and compliance statuses. Stay updated on changes in IVDR, EU regulatory requirements, and industry best practices. Provide training and support to internal teams regarding IVDR compliance and regulatory updates. Team Development and Training Ensure the team have all the knowledge needed to carry out work to a high level. When and where required, identify training and development to guarantee there is a culture of continuous performance, Take part and be responsible for the hiring of new staff. Recognizing where the gaps are and building a team that is motivated, talented and diversified. Design an on-boarding program for new staff that is varied, engaging and ensures they are set up for success, Business Development Drive and implement the sales and business development initiatives to promote Medical certification services, Interface with customers and follow up on leads and sales conversions Addressing technical queries with customers Preparation of effort estimations and commercial proposals Lead generations through public webinars/workshops, representation on relevant forums Customer Relationship Management Building trusted relationships with customers and internal stakeholders Communication with customers on the execution status of the certification activities. Preferred candidate profile Education : Bachelors or Master’s degree in Life Sciences, Engineering, Medical Technology, or a related field. Experience : At least 10+ years of experience in regulatory affairs, technical documentation, or quality management in the medical device or in vitro diagnostics industry. At least 4 years of direct experience with IVDR or its predecessor, IVDD (In Vitro Diagnostic Directive). Experience in preparing and submitting technical files, design dossiers, and risk management documentation for IVD products. Skills & Competencies : Strong understanding of the IVDR and EU regulatory requirements for IVD products. Excellent knowledge of technical documentation practices, including risk assessments, clinical evaluations, and performance studies. Knowledge of ISO 13485 and other relevant standards for medical devices/ invitro devices. Experience working with Notified Bodies and regulatory authorities. Exceptional problem-solving and analytical skills. Excellent organizational and time management abilities Strong communication and project management skills, with the ability to work collaboratively in cross-functional teams. Experience in auditing for IVDR compliance. Relevant exposure to commercial activities/business model.

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams, as well as clients regulatory team, to navigate the regulatory landscape and ensure a smooth and successful product launch. Roles & Responsibilities : Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products. Provide regulatory guidance and support to our engineering and testing teams, ensuring that the system design, development, and testing activities comply with relevant regulations and standards (IEC 62304, FDA guidelines, ISO 13485, etc. ). Assist in the preparation and submission of regulatory documentation, including 510(k) premarket notifications or PMA applications (as applicable), ensuring completeness, accuracy, and adherence to regulatory guidelines. Monitor and track regulatory changes and updates, keeping the team informed of any relevant developments and advising on necessary adjustments to the project plan or system design. Conduct regulatory research and analysis, providing insights and recommendations on regulatory strategies and compliance requirements. Maintain up-to-date knowledge of relevant regulations, standards, and guidance documents related to medical devices. Support internal audits and regulatory inspections, ensuring that all documentation and processes are compliant. Collaborate with cross-functional teams (engineering, quality, marketing) to ensure that regulatory requirements are considered throughout the product lifecycle.

Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile

Executive (RA, QA) ( Level I/ II) Executive (RA, QA) ( Level I/ II) subrat kumar 2025-04-24T12:40:11+05:30 Executive (RA, QA) ( Level I/ II) JC OrthoHeal Private Limited is looking for Executive (RA, QA) ( Level I/ II) to grow our footprints. JOB ID: OHRA250401 Job family Regulatory Affairs Position Title E xecutive (RA, QA) ( Level I/ II) Job Type Full Time Manjuser, Vadodara Nature of Work On-site Company Name JC OrthoHeal Private Limited Updated on 24.04.2025 OrthoHeal is a leading Med-Tech company specializing in orthopedic medical devices. The company focuses on improving post-operative orthopedic recoveries and innovating technologies to enhance patient care. OrthoHeal s flagship product, FlexiOH , is a cutting-edge orthopedic immobilization technology designed for comfort and effectiveness. About the Role: Executive (RA, QA) ( Level I/ II) will work with the regulatory team and Formulate or implement regulatory affairs policies and procedures. Key Responsibilities: Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Develop or compile all the necessary documents required for the regulatory submissions. Maintain the device registration status and ensure timely re-registration. Assist in providing support to the local and international distributors to register devices when required. Collect and analyse data of Legal and Regulatory requirements including mandatory label marking requirements. Assist in training staff in regulatory policies or procedures. Participate in the development or implementation of clinical trial protocols. Supports post market surveillance and vigilance activity when it is required. Maintain and upkeep of all regulatory information, technical file, licenses, and certificates. Draft applicable QMS procedures and formats as per ISO 13485 in the organization. Manage change control activities. Ensure the effectiveness of the quality management system. Set and track quality assurance goals. Documentation and Record keeping. Qualifications: Education : Graduation/ Post Graduate in Science. Skills: Basic computer skills. Able to work in a strict timeline. Strong organizational and persuasive skills. Good verbal and communication skills