Senior Medical Quality Engineer: Regulatory & CAPA Leader

Analog Devices, Inc.; Wilmington (MA); On-site; USD 96,000 - 131,000; Full time

Job summary

Analog Devices, Inc. seeks an experienced Senior Medical Quality Engineer to ensure quality, safety, and regulatory compliance of its medical product portfolio. The role partners with engineering, regulatory, and operations to drive quality across the product lifecycle.

The ideal candidate brings deep MQMS experience, strong problem‑solving, and leadership in audits, CAPA, and process improvements in a global environment. This position offers competitive compensation and comprehensive benefits.

Qualifications

• CAPA, Internal Audits, Document Control, Change Management experience.
• Process Quality systems knowledge incl. CAPA, Risk Management, audits.
• Familiarity with regulatory requirements (FDA, ISO, EU MDR).
• Experience with FDA 510(k)/PMA and EU MDR submissions.

Responsibilities

• Drive MQMS improvements aligned with ISO 13485, 21 CFR 820, EU MDR and other standards.
• Lead quality system processes including CAPA, Internal Audits, Document Control, Change Management, Training and Management Review.
• Own MQMS training architecture, content, delivery, and effectiveness across global teams.
• Serve as SME during audits, including FDA and Notified Body inspections, and manage audit readiness.
• Analyze quality system performance metrics and lead data-driven improvements across functions.
• Provide strategic input for regulatory submissions (FDA 510(k), PMA, EU MDR).
• Ensure 21 CFR Part 11 compliance for electronic records and QA software tools.
• Lead DHF/risk management documentation and post-market surveillance maintenance.
• Collaborate with R&D, Regulatory, Clinical, and Manufacturing to integrate quality systems.
• Mentor engineers on quality principles and continuous improvement methodologies.
• Represent Quality in strategic forums and guide system-level decisions.
• Lead root cause investigations using quality tools (5 Why, Fishbone, FTA).
• Support validation planning/execution for new designs and manufacturing processes.
• Assist in FDA inspections and post-inspection remediation.

Skills

CAPA

Internal Audits

Document Control

Change Management

Training

Management Review

FDA inspections

Regulatory submissions

21 CFR Part 11

Risk Management ISO 14971

Data-driven improvements

Education

BS in Electrical Engineering

MS preferred

Job description

Analog Devices, Inc. seeks an experienced Senior Medical Quality Engineer to ensure quality, safety, and regulatory compliance of its medical product portfolio. The role partners with engineering, regulatory, and operations to drive quality across the product lifecycle.

The ideal candidate brings deep MQMS experience, strong problem‑solving, and leadership in audits, CAPA, and process improvements in a global environment. This position offers competitive compensation and comprehensive benefits.