Senior Quality Engineer
Core
Prepare, compile, and maintain Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) in line with EU MDR and other regulations; investigate product complaints and manage recalls.
Role type
Senior Quality Engineer (Medical Devices)
Builds
PMS documentation, safety update reports, complaint files, recall documentation
Domain
Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis | client delivery
Required skills
root cause analysis, risk assessment, regulatory reporting, audit support, corrective action planning, cross-functional coordination, data analysis, document control, recall execution
Preferred skills
CQE or Six Sigma certification, statistical analysis, Lean Manufacturing, FDA QMSR, MDD, MDR, IVDR, ISO 13485, MDSAP, SAP, Minitab
Responsibilities
Prepare and maintain PMSR and PSUR reports; improve PMS procedures and systems; partner with Regulatory, Clinical, and Quality teams; monitor reporting deadlines; support internal and external audits; investigate product complaints and perform root cause analysis; document findings and corrective actions; ensure timely closure of complaint files; support field corrective actions and recalls; prepare recall documentation and regulatory notifications; coordinate cross-functionally for recall execution; track effectiveness checks; contribute to Risk Management Files.
Seniority
Senior, hands-on IC
