Senior Post-Market Quality Engineer

Basic Function

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.

Location: Must be available to work at our location in Burnsville, MN.

Compensation: The expected annual base salary range for this Minnesota-based position is $110,000-132,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

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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.

Qualifications

• 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.

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Imricor is an equal opportunity employer and encourages diverse candidates to apply.