Senior Medical Quality Engineer - Regulatory & CAPA Lead

Analog Devices; Wilmington (MA); Vor Ort; USD 96.000 - 131.000; Vollzeit

Benefits dieser Stelle

Medical, Vision & Dental

401k

Paid time off

Bonus eligibility

Zusammenfassung

Analog Devices, Inc. in the United States is seeking a Senior Medical Quality Engineer to ensure quality, safety, and regulatory compliance across the medical product portfolio.

You will partner with engineering, regulatory, and operations to drive quality improvements and audit readiness. The ideal candidate brings deep MQMS experience, problem-solving skills, and the ability to guide cross-functional teams through regulatory submissions and quality system governance.

Qualifikationen

• BS in engineering with strong quality background.
• Experience governing product lifecycle quality oversight.
• Familiarity with CFR, ISO, GMP, EU MDR requirements.

Aufgaben

• Drive MQMS improvements aligned with ISO 13485 and CFR 820.
• Lead CAPA, internal audits, document control, change management.
• Own MQMS training architecture and effectiveness monitoring.
• Audit readiness for FDA and Notified Bodies; respond to findings.
• Analyze quality metrics; lead data-driven improvements.
• Support regulatory submissions (FDA 510(k), PMA, EU MDR).
• Ensure 21 CFR Part 11 compliance for electronic records.

Kenntnisse

Quality oversight

Regulatory compliance

Cross-functional collaboration

Problem solving

Auditing

Leadership

Training

Ausbildung

BS in Electrical Engineering

MS degree preferred

Tools

CAPA

Six Sigma

Change control

Statistical Analysis

Control Plans

Document management

Jobbeschreibung

Analog Devices, Inc. in the United States is seeking a Senior Medical Quality Engineer to ensure quality, safety, and regulatory compliance across the medical product portfolio.

You will partner with engineering, regulatory, and operations to drive quality improvements and audit readiness. The ideal candidate brings deep MQMS experience, problem-solving skills, and the ability to guide cross-functional teams through regulatory submissions and quality system governance.