95 Iso 13485 Jobs - Page 4

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 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. In this exciting role as supplier quality engineer II , your primary focus responsibility will be managing suppliers for released product engineering and manufacturing transfers by ensuring suppliers qualification documents are in accordance with the company requirements . You will be a key member of the Medtronic quality engineering team and responsible for coordinating A Day in the Life As a supplier quality engineer II you will be : Responsibilities may include the following and other duties may be assigned. Qualify suppliers according to company standards management of ASL(Approved Supplier List) per Medtronic purchasing control compliance. Support PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ PQ methodology. Manage and release all PPAP deliverables ( such as Control Plan, MSA, PFMEA , FAI etc.) in document control system. Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic test methods. Collaborates with cross functional team to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA,control plans and relevant quality tools and methodologies for new products and legacy product. Provide technical assistance to supplier during product/ process qualification lifecycle, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products. Work with suppliers to support SCAPA s/NCR s in adherence to company standards Required knowledge, experience skills : Bachelors degree in Engineering, Science, or Technical Discipline required and 4+ years of quality systems experience. Experience in supplier management is added advantage . Good communication skills, both oral and written. Comfortable working with international and multi-cultural department and groups in different time zones . Timely accurate delivery quality work. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment. Skills - Nice to have : Good interpersonal skill. Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably). Exposure to FDA Quality System Regulation ISO 13485 standard . Quality certification - CQE. Working knowledge of Standard, Guidance, and Regulations. Lean Six Sigma Yellow belt /Green 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 90,000+ 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 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 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

Strong knowledge of FDA regulation, ISO 13485 and QMS principles Qualification : BSc / MSc / B.Pharm / M.Pharm No. of Vacancies : 1 Experience : 1-2 Years in Medical Devices / Pharmaceuticals or Surgical industy

ql-editor "> We are looking for a dynamic and experienced Head of Engineering to lead our team in the development of portable medical diagnostic products. The ideal candidate should have a strong background in hardware product development, with a good understanding of software and firmware development in a regulated environment. They should ideally be experienced in working with mechanical and optical systems, as well as reviewing electronics, firmware and software teams. Key Responsibilities: Lead and manage the engineering team, ensuring that projects are completed on time and within budget Oversee the development of new microfluidic consumables from concept to commercialization Oversee the development of new generations of hardware devices with integrated firmware and software Work closely with cross-functional teams, including assay development, quality assurance and business development to ensure that products meet customer needs and regulatory requirements Collaborate with external partners and vendors to source components and materials for product development Review and approve engineering designs and specifications, ensuring that they meet quality and safety standards Develop and maintain engineering standards and documentation procedures, ensuring compliance with regulatory requirements Stay up-to-date with industry trends and developments, and incorporate new technologies and best practices into product development Qualifications: Bachelors degree or greater in Engineering or a related field 10+ years of experience in engineering in a commercial organisation, with a focus on hardware development in a regulated environment Experience working with mechanical and optical systems, as well as reviewing and working with firmware/software Strong leadership and management skills, with the ability to motivate and inspire a team Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams Strong analytical and problem-solving skills, with the ability to identify and resolve complex technical issues Proficiency in relevant software and tools, such as CAD, CAM, and simulation software Familiarity with regulatory requirements and quality management systems, such as ISO 13485 and 21 CFR Part 11 This is an exciting opportunity for a highly motivated and experienced engineer to lead the engineering team and drive the development of innovative microfluidics-based diagnostic products. If you have the skills and experience required for this role, we encourage you to apply.

Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, IEC 62304, and ISO 27001 standards. Oversee all quality control activities, ensuring compliance with regulatory requirements and internal standards. Lead and foster a culture of quality excellence. Conduct internal and external audits, identifying and mitigating risks to product quality and patient safety. Collaborate with cross-functional teams to drive continuous improvement initiatives. Manage and reduce quality-related costs while maintaining high-quality standards. Conduct risk assessments and implement risk mitigation strategies. Ensure effective management of non-conformances and corrective actions. Independently lead certification and re-certification audits to maintain compliance with necessary quality standards. Stay abreast of quality standards and industry best practices. Qualifications: Bachelors degree in a relevant field (e.g., engineering, science, quality management). Minimum of 5 years of experience in a quality management role within the medical device or healthcare industry. In-depth knowledge and practical application of ISO 13485, IEC 62304, and ISO 27001 standards. Proven experience in leading and managing quality teams. Strong analytical, problem-solving, and decision-making skills. Excellent communication and interpersonal skills. Experience in conducting audits and inspections. Proven experience in independently leading certification and re-certification audits. Proficiency in quality management software and tools. Benefits: Competitive salary and benefits package Opportunity to contribute to the development of innovative healthcare solutions Collaborative and supportive work environment Professional growth and development opportunities

IB Management: Track PCS Digital Solutions customer complaints, customer satisfaction opportunities, and field modification instructions and ensure rigorous execution as per SLAs. Develop, implement, and maintain robust operating mechanisms to drive consistency and efficiency. IB Metrics Monitoring: Establish and monitor IB metrics and leverage IB teams to drive target achievements. Hazardous Investigations: Handle hazardous investigations with quality rigor, meet SLAs, and prepare and present in leadership reviews. Representation in PCS: Represent Digital Solutions IB in PCS forums as appropriate. Leadership and Talent Development: Lead IB program managers, drive talent development, and succession planning. Rapid Response Team Management: Plan, deploy, and track rapid response teams for new product introductions as required. Continual Improvement Initiatives: Drive continual improvement initiatives to increase rigor and productivity in installed base management Qualifications: Bachelor s degree in engineering, or a related field. A minimum of 15 years of professional experience in software development, with at least 3 years in installed base activities. Experience working with medical devices, including software or systems. Exposure to ISO 13485 or equivalent standards. Desired Characteristics: Strong leadership and team management skills. Excellent communication and interpersonal skills. Proficiency in project management software and tools. Ability to work in a fast-paced, dynamic environment. Strong analytical and problem-solving abilities. Experience in managing finance operations for engineering organization. Proficiency in defining and executing delivery strategies and plans, creating KPIs to measure progress, and working with partner organizations. Experience working in a matrixed organization and utilizing shared resources to achieve program and organizational success.

QC Manager: Title: Quality Control Manager Location: Bangalore, India Organization: Inito (Samplytics Technologies Pvt Ltd) Work Experience: 8 to 12 years Job Description We are seeking a passionate and results-driven Quality Control Manager to lead and inspire a high-performing team in ensuring exceptional product quality and compliance. In this role, you will oversee critical quality control initiatives, including method validation, process optimization, and quality assurance activities, ensuring the delivery of reliable and high-performing products. You will play a pivotal role in maintaining regulatory compliance, driving innovation in QC processes, and fostering a culture of excellence. As a mentor and leader, you will empower your team to excel and contribute to Initos mission of delivering transformative, world-class diagnostic solutions. Final JD: Key Responsibilities : Quality Assurance & Control : Develop and implement robust QA/QC processes to ensure compliance with ISO 13485, FDA CFR 21, industry regulations, and internal standards. Monitor compliance through regular audits, inspections, and investigations (CAPA, OOS, OOT, Deviation, and Incidence). Manage QC systems to address deficiencies and ensure timely corrective and preventive actions. Analytical Excellence : Oversee analytical method development, validation, and verification for Assay, impurities, and residual solvents. Review and approve protocols, test reports, and stability testing records to ensure accuracy and completeness. Documentation & Compliance : Prepare, review, and maintain essential documents, including SOPs, specifications, test protocols, and APQRs. Ensure timely and accurate documentation for regulatory submissions and customer compliance. Collaborate with QA to prepare for audits and regulatory inspections, ensuring adherence to global standards. Team Leadership & Collaboration : Lead and mentor a team of quality professionals, fostering a culture of excellence and accountability. Train staff on QA/QC procedures, regulatory updates, and best practices. Collaborate with cross-functional teams to resolve quality-related issues and implement process improvements. Strategic Oversight : Drive sustainability and innovation in quality management, ensuring timely release of materials and finished products. Stay updated with industry trends and regulatory changes, proactively aligning processes to maintain compliance. Product Development: Should have exp in prod testing and prod dev ISO13485/medical Experience is a plus. Develop testing and quality for new product and work with the design team to set up quality strategy KPI: Build QC Framework for all Existing Products (6 Months) Get Visibility from Centum Get visibility from Optics Internal Assembly Get Visibility from NG Vendor Translate all QC to Vendors and Not do In-House (6 Months) Plastics PCB-A Optics Responsible for Implementing Data Pipeline at all Vendors (6 Months) Also responsible for New Vendor audits for QC capability Responsible for maintaining QC adherence and Data availability at all Vendors Run Audits with all Vendors every 6 months Ensure New Projects are implemented with good standards Run ORT and Ensure Product is Compliant Vendor process is Compliant Responsible for Commissioning and Maintenance of QC Systems and Machines at all Vendor Locations Hire and Build a Self Sufficient Team

Job Title Test Verification Architect Job Description Job title: Test Verification Architect In this role, you have the opportunity to Make a great contribution to the verification of innovative products. You take responsibility for defining verification strategy and leading execution of verification activities. You are responsible for Ensuring right hardware verification strategy by delivering proper test coverage avoiding gap and overlap for release level requirements Leading verification work packages and assigning ownership within TV team Ownership of planning, ensuring timely execution Ensuring high quality of verification evidence ( including compliance with processes, regulations and standards) Boosting the effectiveness of the team by optimization of verification process Supporting/ leading problem solving activities in order to define root cause of the problem Mentoring and supporting team members within design verification process, development of tests methods and test equipment Managing stakeholders within and beyond own team, e.g. project managers, quality, development leads Effective collaboration and communication within cross- functional teams You are a part of You will join the Test and Verification Team, a group within the Product Development Department of Grooming and Beauty Business Unit - located in Drachten. The group consists of 30+ people, highly skilled, flexible, dynamic and multi-cultural. You will support verification of newly developed Philips products. You will work closely with Development Engineers, TV and Quality. To succeed in this role, you should have the following skills and experience Technical background, preferably electrical engineering, mechatronics, physics or comparable subject 3+ years of experience in leading test and verification process 5+ years of experience in RD area or research laboratory Very good understanding of development process and testing (including medical devices (ISO 13485, 21CFR820)) Solid understanding of test method development, MSA methodology/ test method validation, statistical techniques Strong leadership skills and project management skills Strong analytical skills (careful data analysis, effective research, creative thinking and efficient problem solving) Strong sense of ownership, passionate, fast learner Good practice of Windchill and Minitab is an advantage Very good communication skills (English) and social skills since you will be working with colleagues of many disciplines Ability to work in team - flexibility in order to work with and provide support for number of people

Experience in Quality Control inspections (incoming materials, in-process, finished products). Knowledge of report preparation. Knowledge of ISO 13485 is must Perform routine Quality Audits required Interested Candidates Can share Cv @8800096485 Required Candidate profile Experience in Component , pre dispatch, Molded Component & Raw material Inspection at vendor Site. Identify the quality Issue and prepare reports. Sampling and Testing and Identify the quality issue.

Role & responsibilities 'Total 4-7 years of hands on system engineering experience involving electrical, mechanical, firmware out of which at least 3 years for medical devices is compulsory Proficient in product architecture design, define system interface & system verification strategy Proficient in products requirements capturing/ understanding. Proficient in product compliance testing involving mechanical, safety, EMC & environmental tests Good understanding of product reliability and functional safety Familiarity with the Design Controls in Medical Devices Experience in performing Risk Assessment & Control of the Electro-Mechanical Devices Experience in DFMEA, PFMEA, UFMEA and Software Risk Assessment Ability to review/ guide team on verification protocol for electro-mechanical medical device and define acceptance criteria Experience in prototype Manufacturing (Vendor Co-ordination, manufacturing, etc.) Understanding of handling of complete product traceability Experience working with standards such as ISO 13485, ISO 14971, IEC 60601, ISO 10993

Ensure product quality and regulatory compliance (MDR, QMS). Assist in SOPs, audits, documentation, and ISO 13485:2016 compliance. Support QC, microbiological testing, complaints, training, and regulatory updates. Required Candidate profile Experience in ISO 13485:2016, cGMP, EU MDR 2017/745, documentation, QA, and audits. Knowledge of microbiological testing, lab maintenance, compliance, problem-solving, and strong communication.

What you will do- Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities. Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals. Mentor other groups and functions on areas of expertise with particular attention to design and process transfer. Will reside within the regional NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following: Risk Management Inspection Methodology Validation Process Excellence Purchasing Controls Purchasing Controls What you need- Bachelor of Science, Engineering or related subject in Electrical / Electronics / Mechanical with max 1 Year of experience in APQP, New Product development, PPAP and Design Transfers. Candidate working on OEM NPI Team would be desirable Familiarity with advanced product quality planning framework and techniques used to develop products, a distinct advantage. Proficient in understanding of Medical Device manufacturing processes desirable. Familiarity with ISO 13485, QSR, GDP, GMP desirable. Lean Six Sigma training has a distinct advantage. Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks. Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance. Knowledge in selection & development of inspection techniques - automated inspection techniques such as CMM and vision systems a plus. Must be able to generate, follow and explain detailed operating procedures Ability to manage several projects at once. Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams. Basic knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA s. Manages change well and adopts a continuous improvement mindset Excellent English (both oral and written) Ability to be the voice of quality when dealing cross functionally. Travel Percentage: 10%

What you will do: Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls. Collaborate with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs. Support tracking and reporting of KPI and other metrics associated with supplier performance. Articulate detailed supplier performance results and trends to appropriate levels of management. Support Third Party inspection (FDA, Notified Body etc. ) and Stryker Corporate audits of the quality system. Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA) Provide best in class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs. Support local initiatives and projects for improvement, and implementation of processes to build a best in-class Supplier Quality Controls organization. Work with site and divisional counterparts to own Corporate Purchasing Controls NC s and CAPA s (containment actions, root cause, corrective/preventive action, etc. ). Additional duties, as assigned. What you need: Required: B. Tech (Electronics / Electrical / Mechanical) with 2-5 years of experience in Supplier quality. Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements. Ability to effectively communicate information to team members, leaders, management, and suppliers. Experience supporting third-party inspection (FDA, Notified Body etc. ) within the medical device industry. Proficient in MS Office Suite (including Word, Excel, Power Point etc). Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs). Preferred: Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EUs Medical Device Directive. Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams Preferred German Language exposure . ISO 13485 Lead Auditor certification or equivalent Travel Percentage: 10%

Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance. Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability. Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical design reviews. Ensuring full Product Safety Risk Management in a regulation compliant manner. Managing technological complexity of products in multi-disciplinary settings. Develops products, independently and according to own judgement, using the latest technologies and resources, often realizing systems based on unverified specifications. Makes a substantial contribution to the innovation of product and processes. Makes independent choices regarding aspects of the design. Gives reasons for changes in specifications. Formulates assignments in dialogue with customer or user. Submits ideas for future developments and providing tangible input for Technology roadmaps Develops partly and sometimes wholly new product, process or technology. Elicits, reviews, and characterizes stakeholder feedback; creates and reviews system-user interaction model with various Systems Engineering related Methods/tools Youre the right fit if: Bachelors in relevant field including Electrical, Electronics, or other related science. A minimum of 5 years of experience successfully developing complex medical device (hardware, software, consumables) products for acute/emergency care/hospital markets is necessary. Have Systems Engineering certification Hands-on experience in ISO 13485, ISO 14971, ISO 20417, IEC 60601-1 and collateral standards. Hands-on experience in requirements management including, developing, deriving, flow down, tracing and prioritizing requirements. Hands-on experiences in using Model Based Systems Engineering (MBSE) Tools of Cameo and such similar tools. Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic and mechanical performance from subsystem to system level for issue resolutions. Analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions. Strong understanding of Controls and Software development process including Model-based Design approach and Test-Driven design methodologies. Solid understanding of System Verification and Validation test plan/protocols, executing VV (Verification and Validation) (Verification and Validation) activities, generating, and analyzing test reports. Understanding of global medical device regulatory environments and clearance processes. Effective communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. Maintains strict confidentiality of sensitive information.

A Day in the Life As a Senior Quality Engineer you will be a key member of the Medtronic Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through precise risk assessment and management. Responsibilities may include the following and other duties may be assigned Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) 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. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices. Required Knowledge and Experience B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience. Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Fair Knowledge in post market surveillance Familiar with DMAIC or DMADV(DFSS) methodologies 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 90,000+ 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 As a Senior 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. Responsibilities may include the following and other duties may be assigned Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices. 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. 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. Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards. Experience in collaborating with regulatory affairs teams for submission of safety reports. Required Knowledge and Experience B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience. Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.Familiar with DMAIC or DMADV(DFSS) methodologies. 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. 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 90,000+ 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

Work Flexibility: Hybrid Position profile Sr Software Design Quality Engineer Responsibilities and duties Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of ECO/ECR. Effective change control for NPD and Sustaining Products. Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product. Participate in design reviews during various phases of NPD. Work with team to develop robust verification, Design validation & release strategies to ensure product compliance, safety, reliability & effectiveness. Sound knowledge of IEC 62304: Medical device Software - Software life cycle processes. This also includes good exposure to all the phases of Software development life cycle (SDLC). Exposure to any Programming language & on Software Testing concepts. Design And User Validation exposure. Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness. Experience/skills required Bachelors in Computers/ IT/ Electronics. Good analytical and problem-solving skills. Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820) 5-7 years of relevant work experience. Experience on NPD process and various phases of new product development. Knowledge of ISO 14971, IEC 62304, IEC 62366, 60601-1 family of standards. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Expert-level knowledge of current industry standards for New Product Development and risk management practices. Strong knowledge of Quality Concepts (e. g. CAPA, Audits, Statistics). Strong interpersonal skills, written communication and negotiations skills. Travel Percentage: 50%

Seeking Sr. RA Specialist for Product Environmental Compliance. Expertise in medical device regulations, BOMCheck, environmental reporting, and compliance. 5+ years experience in regulatory or product environmental compliance within medical devices

The Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes. Achieves a sales target and increases revenue through selling clients DNV solutions applicable for their businesses. Achieves sales revenue goals in India and other designated markets. Responsible for all sales activities to include certification, audits, training, and full solutions. Develops and implements agreed upon business/marketing plan which will meet business goals by expanding customer base. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments impacting DNV business. Collaborate with Digital Marketing Team to create digital marketing strategies, organize webinars, and follow up for conversion. Works along with the operations/ delivery teams for the achievement of customer satisfaction, revenue generation, and long-term overall account goals. Develops a database-maintained system of qualified leads attained through consultant referrals, face-to-face meetings, calls, direct mail, email, and networking. Connects and actively interacts with Medical Device Industry forums. Sells and makes recommendations to prospects and clients on the various solutions the company offers to solve their business issues. Generates proposals in compliance with Notified /Accreditation Body requirements and/or product sector requirements. Maximizes all opportunities within the process of closing a sale resulting in the taking of market share from competitors. Maintains accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow-up. Gathers and submits detailed business information for pricing. Creates and conducts effective proposal presentations and RFP responses that identify a prospects business challenges. Participates in and contributes to the development of educational programs offered to clients. Maintains effective working team relationships with all support departments. Assists in the implementation of company marketing plans. Communicates and effectively interacts with Global offices for related cost proposal approvals. At all times, complies with DNV Code of Integrity and Professional Conduct. Adheres to internal standards, policies, and procedures. Performs other duties as assigned. Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Experience in the Certification industry would be mandatory.

With a startup spirit and 125,000+ curious and courageous minds, we have the expertise to go deep with the worlds biggest brands and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. Were harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we’re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Permanent role WFO Shift Timings 2 PM -11 PM / 6:30 PM 3:30 AM IST Location – Gurgaon __________________________________________________________________________________________________________________________________________________________________ 1. Job Tile Medical Device Reporng Analyst 2. Job Descripon The Medical Device Reporng Analyst will be responsible for managing and coordinang all aspects of medical device reporng within the organiza¢on or medical device manufacturing company. This posi¢on will play a crucial role in ensuring compliance with regulatory requirements and facilita¢ng the ¢mely and accurate repor¢ng of adverse events and product malfunc¢ons associated with medical devices. 3. Qualica¢ons and Educa¢on • Bachelor's degree in a relevant scien¢c or healthcare discipline (e.g., biomedical engineering, nursing, pharmacology) or equivalent experience. • • • • • • • In-depth knowledge of medical device regula¢ons and guidelines (e.g., FDA, EMA, ISO 13485). Familiarity with adverse event repor¢ng requirements and processes. Strong analy¢cal and problem-solving skills. Excellent a¢en¢on to detail and accuracy. Eec¢ve communica¢on and interpersonal skills. Ability to work independently and collabora¢vely in a team environment. Prociency in using so¢ware applica¢ons for data management and repor¢ng. Medical Device Reporting Analyst GDOCOP-0006-01 __________________________________________________________________________________________________________________________________________________________________ 4. Responsibili¢es and Authori¢es Regulatory Compliance: • Stay up to date with the latest regula¢ons and guidelines related to medical device repor¢ng, including those issued by regulatory bodies such as the U.S. Food and Drug Administra¢on (FDA) or European Medicines Agency (EMA). • Ensure compliance with applicable regula¢ons and standards throughout the repor¢ng process. Adverse Event Repor¢ng: • • • • Receive, review, and evaluate reports of adverse events or incidents associated with medical devices. Conduct thorough inves¢ga¢ons and gather relevant informa¢on to determine reportability. Assess the severity and impact of adverse events on pa¢ents or users. Determine if events meet the criteria for medical device repor¢ng and escalate as necessary. Documenta¢on and Record Keeping: • • • • Maintain accurate and complete documenta¢on related to adverse event reports. Ensure ¢mely and appropriate entry of data into the designated repor¢ng system or database. Monitor and track the progress of inves¢ga¢ons, follow-up ac¢ons, and report submissions. Prepare and maintain necessary records, les, and documenta¢on in accordance with regulatory requirements. Repor¢ng and Communica¢on: • • • • Prepare and submit medical device reports (MDRs) or vigilance reports to regulatory authori¢es within the prescribed ¢melines. Collaborate with cross-func¢onal teams, including quality assurance, regulatory aairs, and medical aairs, to gather relevant informa¢on for repor¢ng purposes. Communicate with regulatory authori¢es, customers, and internal stakeholders regarding medical device repor¢ng ma¢ers. Provide guidance and support to internal teams on medical device repor¢ng requirements. Medical Device Reporting Analyst GDOCOP-0006-01 __________________________________________________________________________________________________________________________________________________________________ Process Improvement and Training: • • • Iden¢fy areas for process improvement and implement correc¢ve ac¢ons to enhance the medical device repor¢ng process. Develop and deliver training programs on medical device repor¢ng regula¢ons, procedures, and best prac¢ces to internal sta as needed. Par¢cipate in internal and external audits to ensure compliance and address any ndings or observa¢ons related to medical device repor¢ng. Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. 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We continuously expand our core capabilities by collaborating with universities, hospitals, research groups, startups, and healthcare companies. By staying at the forefront of scientific and technical developments, we deliver cutting-edge products to our customers. We believe in attracting talented individuals, investing in their development, and providing equal opportunities for success. We actively recruit talent with core healthcare capabilities from diverse geographies to join our inclusive team. Together, we aim to revolutionise the healthcare industry and make quality and affordable healthcare accessible to all. Join Motherson Health & Medical and be part of our mission to make a positive impact on global healthcare. What you'll do Key Position in Central Team of Motherson Health & Medical to shape, plan and execute Regulatory strategies for Products as part of Organic growth as well as interfacing with Inorganic growth opportunities to assess regulatory risks and build a mitigation plan to enable the company scale up the business. Closely work with top management at Motherson Health & Medical Corporate for Regulatory Affairs & Quality Management Systems deployment and adherence at various locations of Motherson. Provide Leadership and coordinate with cross functional teams to deliver Safe,Effective & Regulatory compliant Products to customers following the QCDMSES (quality, cost, delivery, development, management, safety, environment & sustainability) process. Ensure right level of Processes, training and personnel are placed to support all Regulatory deliverables from Product Development, Go to Market, Product Certifications & Post Market Regulatory expectations. To be one point of contact for all communications for internal and External regulatory bodies to obtain and maintain Certifications for Site and Medical devices and components. Provide leadership and direction for the leadership functions. Ensure Compliant Quality Culture, open and effective communication in the Business around global locations. Liaison with all external regulatory & certifying bodies to enable certifications and its audits. Periodic reporting of health of the Regulatory Status of Products at site to the top management. To ensure pre-market and Post Market regulatory expectations for products are met. Ensure the manufacturing facility & Product Development teams follows GDP, GMP, technically sound, safe and environmentally acceptable manner by complying with Quality Policy & ISO 9001,13485 requirements and other relevant regulations and best practices. Ensure Quality Culture Mindset development at the site. Ensuring Training within organization in adherence to the applicable regulations & enabling the same within the QMS established. Documentation support to facilitate ISO 13485, FDA license and Schedule M compliance. Select, manage coach and develop staff, in line with Motherson values and HR requirements and procedure. Effectively engage in NPI activity to outline the component, product or services regulatory requirement from day one. To build and develop best in class quality regulatory team in Health & Medical division including its supplier base. What we offer The team is growing at the same time our Group grows. Therefore there are many opportunities for you to grow with us! We show our commitment to our people via the following values: Interest for each other: We act with empathy and care about each other and about our counterparts. Togetherness: We work together collaboratively and selflessly. Trust: Hard to gain and easy to lose, therefore we say what we mean, keep our promises and treat others with respect. Respect: We respect and value people of all backgrounds. Respect is a common ground we work with each other. Enthusiasm: We are curious, ambitious, passionate, humble and life-long eagerly learners. What we are looking for At least 15-20 years experience in relevant industry like Medical Device OR Healthcare with ISO 13485, 21CFR 820 or cGMP regulated environment with Experience in Regulatory certifications & bodies that include but not limited to FDA 510(k), MDD/MDR CE Marking, CDSCO and various other market needs. Proven problem solving, trouble shooting and Outcome focused Mindset. Experience with leading Medical devices Cross functional teams in regulatory filling and certification activities. Experience in New products Go to Market Regulatory Planning & working with Regulatory bodies to submit required documentation to enable product certifications. Knowledge and educational level: BE or BTech. or high or equivalent Degree. MBA is added preference. Working Knowledge of Regulatory Resources & Added certifications Ex: RAPS, regulatory trainings and certifications. Working knowledge & experience of regulatory requirements pertaining to Medical devices. Should have excellent People management & Communication skills.