Senior Quality Engineer
Core
Lead post-market surveillance activities, complaint investigations, and risk assessments for interventional cardiology devices.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Post-market regulatory deliverables, risk management strategies, and quality system improvements.
Domain
Healthcare / Medical Devices / Interventional Cardiology
Required skills
Post-market surveillance, complaint handling, root cause analysis, risk assessment, regulatory submissions, statistical analysis, CAPA management, FMEA review, process improvement
Preferred skills
Cardiovascular/implant procedure knowledge, signal detection methodologies, cross-functional project leadership
Technologies
None explicitly listed
Responsibilities
Lead complex complaint investigations and root cause analyses; drive complaint trending and emerging risk identification; support regulatory submissions and health authority responses; partner with cross-functional teams to resolve quality issues; mentor junior engineers; lead development of Periodic Safety Update Reports (PSURs) and Post-Market Clinical Follow-up activities.
Seniority
Senior, hands-on IC with mentorship responsibilities
