Senior Post-Market Quality Engineer: CAPA Leader

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

Job summary

Imricor Medical Systems Inc. in Minnesota seeks a Senior Post-Market Quality Engineer to ensure safety and regulatory compliance of medical devices throughout their lifecycle.

You will analyze post-market data, drive CAPA, contribute to PM surveillance plans, and work with Regulatory, Clinical, Operations, and R&D to implement improvements that enhance patient safety and product performance. The role requires a bachelor’s degree in engineering, 5+ years in post-market quality, and experience in

Qualifications

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

Responsibilities

• Collect, analyze, and trend post-market data.
• Support CAPA initiatives and post-market surveillance activities.
• Prepare post-market surveillance plans and PSURs.
• Assist in risk management updates in ISO 14971 framework.
• Collaborate with Regulatory, Clinical, Operations, and R&D teams.
• Support internal/external audits related to post-market activities.

Skills

Strong communication skills

Statistical analysis

CAPA processes

Education

Bachelor’s degree in engineering or related field

Job description

Imricor Medical Systems Inc. in Minnesota seeks a Senior Post-Market Quality Engineer to ensure safety and regulatory compliance of medical devices throughout their lifecycle.

You will analyze post-market data, drive CAPA, contribute to PM surveillance plans, and work with Regulatory, Clinical, Operations, and R&D to implement improvements that enhance patient safety and product performance. The role requires a bachelor’s degree in engineering, 5+ years in post-market quality, and experience in