Senior Quality Engineer

Duration:
Permanent

Job Description:

A leading medical device organization is seeking two Quality Engineering professionals to join its Risk Management team. These openings include one Senior Quality Engineer and one Principal Quality Engineer
, each supporting the safety, reliability, and compliance of integrated software and hardware medical devices.

The Risk Management group owns top‑level and subsystem‑level risk documentation across multiple product lines, supporting ongoing sustaining engineering activities, design changes, corrective actions, and audit readiness. These roles collaborate closely with engineering, regulatory affairs, and operations to ensure compliance with ISO 14971 and ISO 13485 standards.

The Senior Quality Engineer will focus on executing risk analyses, updating risk documentation, and supporting product lifecycle changes. The Principal Quality Engineer will serve as a technical leader, advancing the risk management strategy, overseeing documentation, and mentoring team members.

Both roles offer the opportunity to influence product safety initiatives, optimize risk management processes, and collaborate within a highly regulated, innovation‑driven environment.

• Own and maintain PFMEAs, top‑level risk files, and supporting documentation for multiple product lines
• Perform detailed risk analyses including FMEA, risk matrices, and safety risk assessments
• Support sustaining engineering activities, including design changes and corrective actions for field issues
• Ensure risk documentation and processes comply with ISO 13485 and ISO 14971
• Partner cross‑functionally to communicate risk strategies during internal and external audits
• Support remediation and updates to high‑volume risk files (top‑level: ~30; lower‑level: hundreds)

• Serve as the subject matter expert for ISO 14971 risk‑management processes
• Lead development, governance, and maintenance of top‑level risk documentation
• Oversee corrective actions and resolution of field‑related quality issues
• Ensure audit readiness and maintain alignment with regulatory expectations
• Mentor Senior Quality Engineers and provide technical leadership in risk analysis
• Drive continual improvement of risk management frameworks and documentation practices

• Bachelor’s degree in Engineering, Quality Management, or related field
• 6–8+ years of experience in a regulated medical device or pharmaceutical environment
• 4–5+ years of medical‑device risk management experience (patient monitoring preferred)
• Proven PFMEA ownership and update experience
• Familiarity with adverse event reporting and safety risk analysis
• Experience with integrated software/hardware medical devices (SaMD)
• Working knowledge of ISO 13485 and ISO 14971

• ASQ certifications (CSQE, CQE, SSBB, SQE)
• Master’s degree in a relevant field
• Experience with in large enterprise organizations

• Bachelor’s degree in Engineering, Quality Management, or related discipline
• 10–12+ years in a regulated medical device environment
• 5+ years of supervisory or risk‑management leadership experience
• Expertise in PFMEA, risk matrices, and safety risk methodologies
• Strong understanding of ISO 13485 and ISO 14971 compliance requirements
• Experience with integrated software and hardware (SaMD)
• Proven leadership in audit preparation and corrective action oversight

• ASQ certifications and QMS Lead Auditor credential
• Experience supporting global compliance frameworks at an enterprise scale