Staff Medical Quality Systems Engineer

What You'll Do

• Drive strategic improvements and long-term planning for the Medical Quality Management System (MQMS) in alignment with ISO 13485, 21 CFR 820, EU MDR, and other applicable standards and regulations.
• Lead the development, implementation, and governance of quality system processes including CAPA, Internal Audits, Document Control, Change Management, Training, and Management Review.
• Own the training process architecture for MQMS, including development of training content, delivery strategy, and effectiveness monitoring across global teams.
• Serve as a subject matter expert during internal and external audits, including FDA and Notified Body inspections, and lead audit readiness and response activities.
• Analyze quality system performance metrics, identify systemic trends, and lead cross-functional initiatives to drive data-driven improvements.
• Provide strategic input and technical leadership for regulatory submissions, including FDA 510(k), PMA, and EU MDR documentation.
• Provide strategic oversight for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities, ensuring compliance with 21 CFR Part 11 and alignment with evolving regulatory expectations.
• Ensure compliance with 21 CFR Part 11 for electronic records and signatures, including validation and oversight of quality system software tools.
• Lead the definition and maintenance of design history files, risk management documentation, and post-market surveillance processes.
• Collaborate with R&D, Regulatory Affairs, Clinical, and Manufacturing teams to ensure seamless integration of quality systems throughout the product lifecycle.
• Mentor and coach engineers and cross-functional partners on quality system principles, regulatory expectations, and continuous improvement methodologies.
• Represent the Quality function in strategic forums and influence decision-making through expert guidance and system-level insights.
• Lead root cause investigations and failure analysis efforts using advanced quality tools and methodologies, ensuring robust corrective and preventive actions.
• Support validation planning and execution for new product designs and manufacturing processes, ensuring alignment with quality and regulatory requirements.
• Provide leadership and support for FDA and other regulatory inspections, including pre-inspection readiness, real-time engagement, and post-inspection remediation.
• Required Skills and Qualifications Bachelor’s degree in Engineering, Life Sciences, or a related technical field (Master’s preferred).
• Minimum 5+ years of experience in the medical device industry.
• Extensive experience in quality oversight and management of products throughout the development and commercialization lifecycle.
• Expert-level understanding of global regulatory requirements including FDA QSR, ISO 13485, ISO 14971, EU MDR, and GMP.
• Proven leadership in developing and managing quality systems, including CAPA, change control, document management, and training systems.
• Demonstrated success in leading audits and inspections, including FDA and Notified Body engagements.
• Strong knowledge of FDA 510(k), PMA, and ongoing submission maintenance requirements.
• Advanced proficiency in quality tools and methodologies such as Six Sigma, Statistical Analysis, Control Plans, and eQMS platforms.
• Experience in risk management practices aligned with ISO 14971 and post-market surveillance integration.
• Expertise in root cause analysis using tools such as 5 Whys, Fishbone, and Fault Tree Analysis.
• Exceptional communication, leadership, and cross-functional collaboration skills.
• Lean, Six Sigma, or other continuous improvement certifications are highly desirable. #LI-TK1 For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S.
• Department of Commerce - Bureau of Industry and Security and/or the U.S.
• Department of State - Directorate of Defense Trade Controls.
• As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.
• We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
• Job Req Type: Experienced Required Travel: Yes, 10% of the time Shift Type: 1st Shift/Days