About Analog Devices Analog Devices, Inc. (NASDAQ: ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge.
ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world.
With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's PossibleTM.
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The Staff Medical Device Quality Systems Engineer is responsible for the strategic oversight, development, and continuous improvement of the Medical Quality Management System (MQMS).
This role ensures compliance with global regulatory requirements and drives quality system maturity across the organization.
The Staff Engineer leads cross-functional initiatives, mentors peers, and influences quality culture and regulatory readiness at a global scale.
Key Responsibilities Drive strategic improvements and long-term planning for the Medical Quality Management System (MQMS) in alignment with ISO *****, 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.
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.
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