Senior Post-Market Quality Engineer

This Senior Post-Market Quality Engineer position is responsible for ensuring the safety, effectiveness, and regulatory compliance of marketed medical devices throughout their lifecycle. This role supports post-market data analysis and trending, complaint handling, post-market surveillance plans/reports, corrective and preventive action (CAPA), risk management, and other activities. This position collaborates cross-functionally with Regulatory, Clinical, Operations, and R&D to identify trends, investigate product issues, and implement quality improvements that enhance patient safety and product performance.

Responsibilities

Collect, analyze, trend, and present post-market data; Evaluate post-market data to identify emerging issues and drive continuous improvement efforts; Initiate and support Corrective and Preventive Actions (CAPA) resulting from complaints, audits, trending, and other post-market information; Authors post market surveillance plans/reports and periodic safety update reports (PSUR); Support evaluation of complaints for reportability under applicable FDA, EU MDR, and other global reporting requirements; Conduct and support complaint investigations to determine root cause and product impact; Support Health Hazard Evaluations (HHE) and assessment of product issues that may require field actions; Participate in internal/external audits and support responses related to post-market activities; Review and update risk management files based on post-market data in accordance with ISO 14971; Performs other related duties and responsibilities, as assigned.

Requirements

Bachelor's degree in engineering or related field; 5+ years' experience in Post Market Quality or related field; Experience working in an EU MDR/FDA/ISO 13485 regulated environment; Experience in complaint investigations, reporting, risk management (ISO 14971), CAPA, and statistical analysis/trending; Strong communication skills, both verbal and written.

Benefits

Medical; Dental; Vision; Health Savings Accounts; Health Care & Dependent Care Flexible Spending Accounts; Disability Benefits; Life Insurance; Retirement Benefits