Senior Post-Market Quality & Regulatory Engineer

Imricor; Burnsville (MN); On-site; USD 110,000 - 132,000; Full time

Job summary

Imricor is seeking a Senior Post-Market Quality Engineer to ensure safety, effectiveness, and regulatory compliance of our medical devices throughout their lifecycle. You will lead post-market data analysis, CAPA initiation, and collaboration with Regulatory, Clinical, Operations, and R&D to drive safe, compliant product improvements.

The role requires 5+ years in post-market quality within EU MDR/FDA/ISO 13485 environments, experience in complaint investigations, risk management (ISO 14971),

Qualifications

• Bachelor’s degree in engineering or a related field.
• 5+ years of experience in Post Market Quality or related field.
• Experience in EU MDR, FDA, and ISO 13485 regulated environments.
• Experience in complaint investigations, reporting, risk management (ISO 14971), CAPA, and trending.
• Strong verbal and written communication skills.

Responsibilities

• Collect, analyze, trend, and present post-market data.
• Evaluate post-market data to identify issues and drive improvements.
• Initiate and support CAPA activities from complaints, audits, and trends.
• Authors post-market surveillance plans/reports and PSURs.
• Support evaluation of complaints for regulatory reportability under FDA/EU MDR.

Skills

Post-market quality

CAPA

Statistical analysis

Communication skills

Education

Bachelor's degree in engineering or related field

Job description

Imricor is seeking a Senior Post-Market Quality Engineer to ensure safety, effectiveness, and regulatory compliance of our medical devices throughout their lifecycle. You will lead post-market data analysis, CAPA initiation, and collaboration with Regulatory, Clinical, Operations, and R&D to drive safe, compliant product improvements.

The role requires 5+ years in post-market quality within EU MDR/FDA/ISO 13485 environments, experience in complaint investigations, risk management (ISO 14971),