Senior Quality Engineer Post Market Surveillance (Wayne, NJ)

Requirements

• - Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline - Minimum 5 years of experience in Quality Assurance, Post-Market Surveillance, or Regulatory Affairs within the medical device industry - Demonstrated experience leading complaint handling, vigilance reporting, signal detection, and PMS documentation for Class II/III medical devices - Preferred: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC) - Strong working knowledge of FDA 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR (Annex III) - Proficiency in PSURs, PMSRs, and inputs to CERs; data analysis and visualization tools (Excel, Minitab, Tableau) - Experience with TrackWise, Windchill or other electronic QMS/complaint systems - Excellent verbal and written communication skills; ability to interact with regulatory authorities and cross-functional teams - Ability to mentor or coach junior engineers; leadership capabilities - Willingness to work in Wayne, NJ and travel as needed