130 Iso 13485 Jobs - Page 2

Job Description Summary In this role you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have In-depth understanding of key business drivers; uses this understanding to accomplish own work. You will ensure each project is developed & released meeting customer expectations and regulatory requirements . GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Supports continuous product and process improvement through detailed failure analysis for nonconformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications This role requires advance experience in ISO 13485 and SDLC 62304 domain in a regulated industry (such as FDA, EUMDD/MDR) . Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Minimum Years of experience in the relevant industry - 5 to 10 Years or more Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to ISO 13485 and FDA 21 CFR 820. Inclusion and Diversity . Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Relocation Assistance Provided: No

Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Regulatory Specialist - Technical Writer to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medical devices (hardware and software), with a focus on ensuring compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and others. Key Responsibilities: Regulatory Documentation & Submissions. Prepare and maintain high-quality regulatory documentation including: Technical Files / Design Dossiers Clinical Evaluation Reports (CERs) Risk Management Files Declarations of Conformity FDA submissions (510(k) or pre-submissions, if applicable) Collaborate with cross-functional teams to gather inputs from R&D, QA, Clinical, and Marketing for submission documents. Technical Writing: Write, edit, and proofread SOPs, work instructions, user manuals,labeling, and IFUs to ensure technical accuracy and regulatory compliance. Translate complex technical data into clear, concise, and user-friendly documentation. Compliance & Standards: Stay current with regulatory changes (EU MDR, FDA, etc.) and update internal documentation and processes accordingly. Ensure documentation aligns with applicable standards such as: ISO 13485. ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) IEC 60601 (Electrical Medical Devices) EU MDR 2017/745 FDA 21 CFR Part 820 Quality System Support: Support internal audits and inspections by maintaining complete and audit-ready documentation. Assist in CAPA documentation and post-market surveillance reports when required. Required Qualifications: Bachelor s or master s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. 3-5 years of experience in regulatory writing or regulatory affairs in a medical device or healthcare product environment. Strong knowledge of global medical device regulatory frameworks (FDA, EU MDR, etc.). Excellent written English and technical writing skills. Strong organizational and project management skills. Preferred Qualifications: Experience preparing 510(k), CE Mark, or similar submissions. Familiarity with digital pathology, imaging devices, or software as a medical device (SaMD). Certification in Regulatory Affairs (e.g., RAPS RAC) is a plus.

Key Responsibilities : Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable international quality standards. Support design control, risk management, validation, and verification processes for scanners and software. Maintain and improve the Quality Management System (QMS) across departments. Review and approve SOPs, DHRs, DHFs, CAPAs, NCRs, and change controls. Conduct internal audits and support external audits (e.g., customer, notified bodies, FDA). Collaborate with engineering, manufacturing, and regulatory teams to ensure product quality at every stage of the lifecycle. Support software validation and documentation of AI algorithms per FDA/CE/MDR requirements. Participate in supplier qualification and vendor audits. Monitor and report on key quality metrics (e.g., defect rates, complaints, CAPA status). Ensure traceability and document control throughout product development and release. Qualifications: Bachelor s degree in biomedical engineering, Quality, Life Sciences, or related field. 3-6 years experience in a medical device, diagnostics, or regulated health tech environment. Familiarity with digital pathology, AI in healthcare, imaging devices, or SaMD is a plus. Strong knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QSR, and EU MDR/IVDR regulations. Experience with QMS tools, document control systems, and audit practices. Excellent written and verbal communication skills. Detail-oriented, with strong problem-solving and cross-functional collaboration abilities.

Additional Locations: India-Haryana, Gurgaon Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Key Responsibilities: Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining. Investigates and evaluates the compliance requirements driven from organization s QMS/Work Instructions and validate the same in templates developed in RM tool. Investigates and evaluates existing RM tools/technologies - JAMA, Polarion, Cockpit etc. Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents. Performs validation of patches and versions of RM tool as and when available. Support multiple projects across different time zones - Asia, Ireland, and North America Qualifications Required: Mechanical Engineering ( B.E./B.Tech) with 4-5 years of experience Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit Knowledge of MS Office Tools - Word, Excel, PowerPoint. Strong attention to detail with good communication skills. Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making. Ability to collaborate and work as a team player. Nice to have experience in product lifecycle management software and tools. Willingness to work in an agile environment. Requisition ID: 610104 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Senior Systems Engineer Location: India (Remote) Welcome to Natus Medical Incorporated: We re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Job Summary: The Senior Systems Engineer is responsible for the risk management (RM), design and requirements specification, usability engineering, and compliance engineering of medical electrical systems used in Neurology, Audiology, and Newborn Care products. You can expect to be involved in all phases of the product lifecycle, for both new product introductions and maintenance of existing products. This role entails a special focus on RM for post-market activities. In this job, you will: Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers Execute risk analysis activities using FTAs, FMEAs and similar tools Analyze production and post-market data to identify changes to product risk Apply ISO 13485, ISO 14971, US FDA Quality System Regulations (21 CFR 820), EU MDR and relevant international standards to systems engineering group Participate in developing design controls procedures for application to legacy products and new product development Identify and maintain traceability between risk control measures and product requirements and verification / validation Take guidance from the lead risk management engineer for risk management responsibilities and improvements Coordinate activities with contributors from regulatory and quality affairs, clinical, marketing, and cross-functional engineering disciplines Participate in quality improvement, complaints investigation, change control, and safety assessment processes Contribute to harmonizing the company s various medical device platforms by converging system architecture and reusing components as well as design and test practices (product line engineering), specifically related to risk analysis Travel: up to 25% domestic or international travel Qualifications: Bachelor s degree in Engineering or Science; Master s degree is an asset Minimum 7 years systems engineering relevant experience and/or training 5+ years experience in the medical device industry working with applicable quality and safety standards, and regulations Experience with risk management process and tools; requirements specification and traceability Experience with CAPAs and DHF remediation for legacy products Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments Experience with project management a plus. EEO Statement Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status. #LI-SH1 #IND-NATUS

Job Title Principal Test Architect - Strategy & Automation Job Description Join Philips as a Principal Test Architect - Strategy & Automation for Image Guided Therapy (IGT) Systems and take a leading role in shaping the long-term verification & validation strategy for our X-ray system modality. This is a principal-level role, responsible for defining multi-year test strategies, advancing automation frameworks, and ensuring compliance with global regulatory standards. You will drive enterprise-level test architecture, collaborating with system architects, project architects, and development leaders to embed best-in-class test methodologies. Your work will influence the entire product lifecycle, from design to manufacturing and post-market, ensuring high-quality, compliant medical imaging solutions. Your role: Develop and own the long-term strategic vision for test architecture, automation frameworks, and validation processes across IGT Systems. Ensure alignment between verification & validation strategies and Philips broader business objectives. Define and drive the adoption of cutting-edge test methodologies, leveraging automation, AI-driven testing, and risk-based validation. Collaborate closely with system architects, development cluster managers, and regulatory specialists to optimize testing across global R&D sites (Netherlands, China, and India). Lead the harmonization of test processes across multiple product lines, ensuring scalability, efficiency, and compliance with IEC 62304, ISO 13485, and FDA 21 CFR Part 820. Act as a senior advisor to leadership on test strategy, influencing investment decisions in test infrastructure and automation capabilities. Mentor and guide test architects and engineering teams to elevate test excellence across the organization Youre the Right Fit If You Have M.Sc. in Software Engineering, Electrical Engineering, or a related field. 10+ years of experience in test architecture, system verification, or quality assurance within complex, regulated industries (e.g., medical devices, automotive, aerospace). Expertise in enterprise-level test strategy development, with a proven track record of implementing large-scale automation frameworks. Deep regulatory knowledge (IEC 62304, ISO 13485, FDA regulations) and experience in embedding compliance into test processes. Strong leadership, stakeholder management, and influencing skills, with experience engaging with senior technical leaders and business executives. Advanced ISEB/ISTQB certification and hands-on experience with industry-standard test tools and methodologies. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. This role is an office role. #LI-EU #LI-Hybrid #LI-PHILIN

Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO. Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments). Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants. Support Quality Assurance in audits, product recalls, and field safety corrective actions. Ensure compliance with India-specific labeling, documentation, and advertising regulations. Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams. Maintain regulatory files and tracking systems for timely renewals and updates. Collaborate with global regulatory teams to ensure consistent strategies and compliance. Requirement: Master s degree in Pharmacy or a related field 5 8 years of hands-on experience in regulatory affairs for medical devices and experience with Class C & D devices preferred Strong knowledge of CDSCO regulations and submission pathways Excellent communication and project management skills Familiarity with ISO 13485, EU MDR, and US FDA regulations is a plus

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Purpose Statement: Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. This role ensures that systems meet intended use, regulatory requirements, and quality standards through rigorous testing and analysis. Key Responsibilities: Define and implement system-level V&V strategies, including test plans, protocols, and traceability to requirements. Lead the development and execution of test cases for hardware/software integrated systems. Analyze system behavior and performance, identify root causes of failures, and recommend corrective actions using tools like FMEA, 5 Whys, and fishbone diagrams. Collaborate with cross-functional teams to ensure test coverage aligns with system architecture and risk assessments. Develop and maintain dashboards and reporting tools to track test coverage and defect trends. Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) and internal quality systems. Drive continuous improvement of V&V processes and tools to enhance efficiency, traceability, and test automation. Participate in design reviews and provide input on testability, reliability, and system integration risks. Solves system problems by analyzing the situation and recommending corrective or alternative actions. Detailed oriented engineer who owns the quality of the project. Develop robust, scalable systems for managing NCEP and CAPA process. Directs support personnel and project activities. Lead engineers in Systems V&V activities/methodologies and medical domain knowledge. Desired Experience and Skills: Bachelor s or Master s degree in Engineering (BE, BTech, ME, MTech) or equivalent. 13+ years of experience in systems-level V&V and product testing, good understanding of automation. Experience in regulated product development, preferably in the medical device industry. Proficiency in test management tools, defect tracking systems, and data analysis platforms. Demonstrated ability to lead cross-functional projects and mentor technical teams. Deep knowledge of systems engineering and V&V principles. Strong analytical and problem-solving skills. Effective communication and leadership in cross-functional settings. Highly accountable and responsible Commitment to quality, safety, and continuous improvement. Requisition ID: 609679 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Purpose Statement: Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. This role ensures that systems meet intended use, regulatory requirements, and quality standards through rigorous testing and analysis. Key Responsibilities: Define and implement system-level V&V strategies, including test plans, protocols, and traceability to requirements. Lead the development and execution of test cases for hardware/software integrated systems. Analyze system behavior and performance, identify root causes of failures, and recommend corrective actions using tools like FMEA, 5 Whys, and fishbone diagrams. Collaborate with cross-functional teams to ensure test coverage aligns with system architecture and risk assessments. Develop and maintain dashboards and reporting tools to track test coverage and defect trends. Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) and internal quality systems. Drive continuous improvement of V&V processes and tools to enhance efficiency, traceability, and test automation. Participate in design reviews and provide input on testability, reliability, and system integration risks. Solves system problems by analyzing the situation and recommending corrective or alternative actions. Detailed oriented engineer who owns the quality of the project. Develop robust, scalable systems for managing NCEP and CAPA process. Directs support personnel and project activities. Lead engineers in Systems V&V activities/methodologies and medical domain knowledge. Desired Experience and Skills: Bachelor s or Master s degree in Engineering (BE, BTech, ME, MTech) or equivalent. 13+ years of experience in systems-level V&V and product testing, good understanding of automation. Experience in regulated product development, preferably in the medical device industry. Proficiency in test management tools, defect tracking systems, and data analysis platforms. Demonstrated ability to lead cross-functional projects and mentor technical teams. Deep knowledge of systems engineering and V&V principles. Strong analytical and problem-solving skills. Effective communication and leadership in cross-functional settings. Highly accountable and responsible Commitment to quality, safety, and continuous improvement. Requisition ID: 609679 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact. You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements. This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role. In this role, you will be responsible for: Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance. Performs/monitor the laboratory equipment validation / calibration / maintenance and ensure quality control lab as per safety standards/GLP. Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site. The essential requirements of the job include: Master s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience. 2+ years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits Business Schedule Requirement Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines). It would be a plus if you also possess previous experience in: Experience working with medical device quality systems in compliance with MDR and ISO 13485 Experience in leading continuous improvement efforts, in both quality systems and IVD products. Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing whatever your ambitions. Purpose Statement: Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. This role ensures that systems meet intended use, regulatory requirements, and quality standards through rigorous testing and analysis. Key Responsibilities: Define and implement system-level V&V strategies, including test plans, protocols, and traceability to requirements. Lead the development and execution of test cases for hardware/software integrated systems. Analyze system behavior and performance, identify root causes of failures, and recommend corrective actions using tools like FMEA, 5 Whys, and fishbone diagrams. Collaborate with cross-functional teams to ensure test coverage aligns with system architecture and risk assessments. Develop and maintain dashboards and reporting tools to track test coverage and defect trends. Ensure compliance with regulatory standards (e. g. , FDA, ISO 13485) and internal quality systems. Drive continuous improvement of V&V processes and tools to enhance efficiency, traceability, and test automation. Participate in design reviews and provide input on testability, reliability, and system integration risks. Solves system problems by analyzing the situation and recommending corrective or alternative actions. Detailed oriented engineer who owns the quality of the project. Develop robust, scalable systems for managing NCEP and CAPA process. Directs support personnel and project activities. Lead engineers in Systems V&V activities/methodologies and medical domain knowledge. Desired Experience and Skills: Bachelor s or Master s degree in Engineering (BE, BTech, ME, MTech) or equivalent. 13+ years of experience in systems-level V&V and product testing, good understanding of automation. Experience in regulated product development, preferably in the medical device industry. Proficiency in test management tools, defect tracking systems, and data analysis platforms. Demonstrated ability to lead cross-functional projects and mentor technical teams. Deep knowledge of systems engineering and V&V principles. Strong analytical and problem-solving skills. Effective communication and leadership in cross-functional settings. Highly accountable and responsible Commitment to quality, safety, and continuous improvement. Requisition ID: 609679 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Looking for professionals with 5+ yrs exp in document control, QMS (ISO 13485), and change mgmt. Windchill PLM knowledge preferred. Engineering degree required. Immediate to 1-month joiners. sonali.tomar@saracasolutions.com

Job Description: Role Senior Audit Program Manager Experience 8 years of experience Qualification B E Computer Science or Information Technology Engineer Professional Competencies Mandatory ISO Standards CMMI High Maturity Practices Agile DevOps ISO 9001 ITSM CSM DevOps and relevant Industry Certifications around these competencies Preferred CMMI ISO 13485 AS9100D ISO 42001 in addition to above Mandatory Skills PMP Prince 2 CSPO Certified SAFe Agilist 5 0 Certifications can also apply Key Responsibilities: Skills Good knowledge of CMMI Model ISO 9001 standard ITIL practices Distributed Agile methodologies DevSecOps models Hands on experience in practicing and implementing Agile and DevOps practices in both Development and Service Support projects Hands on experience in handling supporting few accounts or programs Strong Analytical Inter Personal Networking and Presentation Skills Ability to coordinate with Senior Stakeholders from Delivery and Quality Ability to extract process deficiencies based on factual data Strong Communication and Articulation Skills Oral Written Preferred PMP ITIL CSPO CSM DevOps Certifications Certified SAFe Agilist 5 Roles Responsibilities Periodic strategizing and planning of audits sampling of accounts Perform and manage end to end Account Level Audit execution alongwith conducting project level audits Seamless execution of audit alongwith Delivery and Quality teams Clear articulation of risks and business impact from conducted audits Key Risks presentation to Delivery and Quality Leadership Monitoring effective closure of audit findings in a timely manner Technical Requirements: Competencies Mandatory ISO Standards CMMI High Maturity Practices Agile DevOps ISO 9001 ITSM CSM DevOps and relevant Industry Certifications around these competencies Preferred CMMI ISO 13485 AS9100D ISO 42001 in addition to above Mandatory Skills PMP Prince 2 CSPO Certified SAFe Agilist 5 0 Certifications can also apply Preferred Skills: Foundational->Quality models/improvement frameworks->ISO 9001,Foundational->Quality models/improvement frameworks->CMMi for Development->CMMI Process Area wise process definitions

Quality Engineer, PMS - Individual Contributor Reports to: Associate Manager, PMQ Trauma & Extremities 1.2 Roles and Responsibilities At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. The Quality Engineer will work on all the various aspects of Post Market Surveillance and enters customer complaints into the company-wide complaint handling system and follows methods to analyze the complaints, for the Trauma & Extremities business. He/She should be competent to compile the Product Safety Usage Reports (PSURs) independently. These activities as they relate to Post Market Surveillance and EU MDR requirements include but are not limited to identifying strategic focus areas for continuous improvements, product/process enhancements, implementing proactive quality activities, monitoring, and measuring the overall performance, and ensuring compliance to quality systems and regulatory requirements. Key Responsibilities include : Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process. Skill Set: Proficient in post market surveillance regulations, specifically EU MDR. Hands on experience of Risk Management process as per ISO 14971 Sound knowledge on complaint trending 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. Applied understanding of GDP, ISO 9001 & ISO 13485, FDA 21CFR Part 822 / 820 Additional: Effective interpersonal communications & Excellent analytical skills. Demonstrated organizational and written/verbal communication skills. Drive self-initiative to improve process Ability to work independently and in a team environment 1.3 Desired Profile Education B. Tech / B.E in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar). Experience: 2 to 4 years of experience in Scientific or Medical Writing, and/or Quality and regulatory experience in post market surveillance. Experience with medical device, orthopedic or trauma devices preferred Personality: Proactive, independent, team player with a strong service mentality. You are characterized by analytical and transdisciplinary reasoning, with a good attention to detail. You value an international working environment, working across sites and indications. Based at: SGTC Based at Location: Gurgaon Post Market Surveillance, Pms, Quality

About Vantive Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Job Summary Job Title - Senior Engineer, Acute Disposables Location - Whitefield, Bangalore Shift - General Job Description You will be responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. The successful candidate will possess solid hands-on technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients. Project tasks involve development and maintenance of risk management files. Active support in Engineering change management with focus on risk, root cause analysis, solutions for CAPAs, NCRs, design implementation, verification & validation, standards compliance activities to ensure maintenance of state of the Art also from risk management perspective. Projects also include the development of new functions and features to be integrated into the existing products/new products. Essential Duties and Responsibilities: Leads the evaluation and development of Disposables on assigned projects with focus on risk management. Owns and maintains the risk management files for the assigned product families. Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones. Collaborates with cross functional team (e.g., Quality, regulatory, clinical) to ensure the proper deployment of risk management activities. Manages and prioritizes multiple projects and tasks. Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques. Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management. Organizes and presents solutions from risk management perspective without assistance. Oral and written communication is well planned, organized and has a clear logical flow. Ensures successful integration of disposables design elements from risk management perspective into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the risk management tasks. Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing ensuring acceptable risk profile of the device is maintained throughout the entire product lifecycle. Support, from risk management perspective, the necessary testing required to validate the safety and effectiveness of the design(s). Education & Experience Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent Minimum of 6 years of relevant experience, Prior experience of technical leadership in Sustenance/New product development in Critical care Medical device domain is a plus. Experience in a regulated industry preferably medical devices and familiarity with ISO 13485, and ISO 14971 Qualifications Proficiency with MS Office and other office productivity tools. Self-directed, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Strong hands-on lab skills, and prototype fabrication skills. Very adept at grasping and solving complex problems using root-cause analysis techniques. Previous experience on product risk management is a plus. Ability to objectively identify technical solutions, and make sound engineering decisions. Clear and effective communication (written and oral) and presentation skills. A proven track record of effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Beckman Coulter LS Beckman Coulter Life Sciences mission is to empower those seeking answers to life s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you ll help drive our vision of accelerating answers and our commitment to excellence. Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. Position Summary and Overview: Responsible for managing the sites Non-conformance (NC) and deviation processes. This includes reviewing and approving NC records, containing non-conforming material, conducting trend analysis, managing related CAPAs, and driving root cause investigations. The role maintains compliant Quality Management System (QMS) procedures for NCs and supports internal and external audits and inspections. Essential Duties and Responsibilities: Reviews and approves all aspects of Non-conformance (NC) records, including initial accuracy, dispositions, investigations, impact assessments, categorization, closure, and due date extensions, ensuring all actions are accurately recorded as per the procedural requirements. Ensures appropriate physical segregation and labeling of nonconforming material in the designated quarantine area. Performs trend analysis on Non-conformances to identify improvement opportunities and manages the system for Corrective Actions (CAPAs) initiated through NCs. Participates in root cause investigations for Non-conformances and other quality issues and presents findings to management. Responsible for the overall handling and management of product-related non-conformances and planned deviations within the site. Maintains and monitors the Quality Management System, including site-specific and global Non-conformance procedures, ensuring full compliance with requirements, regulations, and standards. Supports audit and inspection activities, including preparation, liaison with auditors, and resolution of findings, and performs other related duties as required. Qualification and Experience: Minimum Requirements: Bachelors or master s degree in biology, Engineering or related disciplines Minimum of 5-7 years related experience in quality assurance and/or regulatory affairs Knowledge of ISO 13485, GMP and GLP requirements would be advantageous Experience with handling non-conforming products and other Quality Management System processes. Demonstrated experience in flow cytometry is crucial and will be highly advantageous. Required Competencies: Exceptional communication skills (verbal / written / presentation / relationship building) with ability to work collaboratively with cross-functional project teams and regulators Ability to drive results, foster teamwork, handle pressure, and provide feedback. Must be able to demonstrate skills in root cause investigation and problem solving. Organized, detail-oriented with impeccable integrity. High level of initiative, self-motivation, and energy. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com .

Develop & maintain QMS documentation Ensure compliance with applicable quality standards and regulations Conduct internal audits & support external audits Work with CFT teams to resolve issues Train staff on QMS procedures

Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Capable of mentoring junior quality engineers in providing quality engineering support. Responsibilities may include the following and other duties may be assigned Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Hands on experience with tools package release process for both Software & Hardware tools/accessories Review non product/off-the shelf tools for products Experience in software or hardware design transfer process for tools or products Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance. Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA Ensure successful transfer of new products/tools to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Review Design History Files and Technical Files for conformance to applicable requirements. Participate when appropriate in audits Ensures applicability to SOUP / OTS validations in the product development Participate and provide input to training on department / procedures and policies Hands-on experience on Software Risk Management, Design Controls. Develop templates and training based on the quality system regulations, applicable standards and guidance. Independently reviews all SW deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver training to departments outside of QA. Previous experience working in a cross-functional team environment. Provide Quality support to facilitate resolution of product complaints and/or safety issues Provide support to the Regulatory Department in writing technical submissions. Required Knowledge and Experience B E or B. Tech Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab, Stat Graphics) Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Strong in software design and development, software verification and validation activities Computer literate and experience with PCs, networks, applications, software development life cycle Travel may be required Knowledge in cybersecurity

In this role, you will partner with cross functional team members to generate, analyze, communicate, and follow up on actions related to data analysis/ reporting for: -Field Corrective Actions administrative reconciliation -Service and Repair work order completion for capital correction and Software updates -Inventory management: loaner set tracking and return for inspection/ replenishment to the field -Other quality systems compliance duties (including data analytics) Responsibilities may include the following and other duties may be assigned Generates and analyzes reports (Field Corrective Actions, Product Hold Orders, Field Inventory) for compliance with KPIs, identification of patterns of performance to KPIs Communicates coming due and/or overdue notifications for field based inventory or post market surveillance needs to affected personnel, their management, and Quality leadership Coordinates with internal stakeholders to implement corrections to product master data. Required Knowledge and Experience Bachelor degree; Engineering or Science degrees preferred Quality assurance/ systems 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 generating and running data queries/ reports across applications Strong verbal and written communication skills and ability to work in a team oriented environment Product Lifecycle Management knowledge/ experience Ability to work independently once trained. Ability to multitask.

Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Responsibilities may include the following and other duties may be assigned Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills including plan / report development. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR. Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis. Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on EU MDR. Previous experience working in a cross-functional team environment. Hands-on experience on Risk Management, Design Controls for Medical Devices. Participate when appropriate in audits. Experience in collaborating with regulatory affairs teams for submission of safety reports. Required Knowledge and Experience 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.

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issues and client complaints to create methods to lessen recurring issues. Ensuring First Response Time, Complaint Handle Time, First Contact resolution are within the prescribed limits as directed by the Management. Auditing work and customer service to ensure the company's high standards, efficiency, and productivity goals are met. Ensuring Quality Standards as per ISO 9001, ISO 13485, CE MDD/MDR, USFDA, CDSCO standards and any other applicable standards and systems. Maintaining strong relationships with manufacturers, dealers, and sales representatives. Helping to train new employees in company procedures. Maintaining a strong working knowledge of industry regulations, restrictions, and laws, ensuring the company's adherence to these regulations, and remaining current on the industry's standards and new innovations, materials, tools, and processes.

A Day in the Life Quality Engineer II for risk management & PSUR activities support for CST OU A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. 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. Must Have 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. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR. Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis. 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 analysis, Post market surveillance, Design Controls for Medical Devices. Minimum Qualification B E or B. Tech in Mechanical/Biomedical Engineering Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience Key Technical Competencies 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 Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt 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. 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

Description & Requirements Introduction: A Career at HARMAN Digital Transformation Solutions (DTS) We re a global, multi-disciplinary team that s putting the innovative power of technology to work and transforming tomorrow. At HARMAN DTS, you solve challenges by creating innovative solutions. Combine the physical and digital, making technology a more dynamic force to solve challenges and serve humanity s needs Work at the convergence of cross channel UX, cloud, insightful data, IoT and mobility Empower companies to create new digital business models, enter new markets, and improve customer experiences About the Role Bachelor s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality. . What You Will Do Qualified to assess patient safety risks via one of the following: Medical Doctor with related device experience Engineer who has achieved IBHRE or NASPE Exam certification At least 5 years of clinical field experience in the past 15 years. The relevant field experience could include the following: o Nurse o Field Personnel such as: Clinical Specialist, Technical Field Educator, Field o Clinical Engineer o Technical Services (cardiac products) Personnel with at least 5 years of previous clinical experience related to cardiac therapy products. What You Need Advanced degree in Engineering or Science Proven understanding of reliability engineering principles Strong understanding of and experience in the application of statistics, including experience with Minitab Experience in a highly regulated industry, preferably implantable medical devices Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA) Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms CRE Certified Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices What Makes You Eligible You hold a Bachelor s or Master s degree in Computer Science, Engineering, or a related technical field. Demonstrate strong problem-solving abilities and a deep understanding of backend system design and architecture. You re passionate about clean code , continuous learning, and sharing knowledge with teammates. What We Offer Access to employee discounts on world class HARMAN/Samsung products (JBL, Harman Kardon, AKG etc.) Professional development opportunities through HARMAN University s business and leadership academies. Flexible work schedule with a culture encouraging work life integration and collaboration in a global environment. An inclusive and diverse work environment that fosters and encourages professional and personal development. Tuition reimbursement. Be Brilliant employee recognition and rewards program. You Belong Here HARMAN is committed to making every employee feel welcomed, valued, and empowered. No matter what role you play, we encourage you to share your ideas, voice your distinct perspective, and bring your whole self with you - all within a support-minded culture that celebrates what makes each of us unique. We also recognize that learning is a lifelong pursuit and want you to flourish. We proudly offer added opportunities for training, development, and continuing education, further empowering you to live the career you want. About HARMAN: Where Innovation Unleashes Next-Level Technology Ever since the 1920s, we ve been amplifying the sense of sound. Today, that legacy endures, with integrated technology platforms that make the world smarter, safer, and more connected. Across automotive, lifestyle, and digital transformation solutions, we create innovative technologies that turn ordinary moments into extraordinary experiences. Our renowned automotive and lifestyle solutions can be found everywhere, from the music we play in our cars and homes to venues that feature today s most sought-after performers, while our digital transformation solutions serve humanity by addressing the world s ever-evolving needs and demands. Marketing our award-winning portfolio under 16 iconic brands, such as JBL, Mark Levinson, and Revel, we set ourselves apart by exceeding the highest engineering and design standards for our customers, our partners and each other. If you re ready to innovate and do work that makes a lasting impact, join our talent community today ! Please be aware that HARMAN recruiters will always communicate with you from an @harman.com email address. We will never ask for payments, banking, credit card, personal financial information or access to your LinkedIn/email account during the screening, interview, or recruitment process. If you are asked for .