Senior Engineer, Quality Engineering

Analog Devices•Wilmington, MA

17h•Onsite

About The Position

We are seeking an experienced and highly motivated Senior Medical Quality Engineer to join our dynamic team. This role plays a critical part in ensuring the quality, safety, and regulatory compliance of our medical product portfolio. The ideal candidate will bring deep experience in medical device quality systems, strong technical problem‑solving skills, and the ability to partner effectively across engineering, regulatory, and operational teams.

Requirements

BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process Engineering, or related technical disciplines. An MS degree is preferred.
Demonstrated experience in quality oversight and management of products through the lifecycle of product development.
Experience supporting quality systems, practices, and policies.
Familiarity with regulatory requirements including US CFR (Code of Federal Regulation), ISO (International Organization for Standardization), GMP (Good Manufacturing Practice), and EU MDR (Medical Device Regulation).
Knowledge of FDA 510(k) clearance, FDA Premarket Approval (PMA), and ongoing submission maintenance requirements.
Experience with the use of quality systems and tools (for example, CAPA, Six Sigma methodology, change control, Statistical Analysis, Control Plans, and document management)
Experience supporting Risk Management, for instance, ISO 14971 standard.
Experience directing root cause analysis using quality tools, such as 5 Why, Fishbone Analysis, and Fault Tree Analysis.

Responsibilities

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.
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.