Senior Post-Market Quality Engineer | CAPA & Risk

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

Job summary

Real Staffing is assisting a medical device company in Burnsville, MN to hire a Senior Quality Engineer responsible for post-market surveillance, complaint handling, CAPA, risk management, and regulatory compliance across marketed products.

You will partner with Regulatory, Clinical, Operations and R&D teams to analyze data, investigate issues, drive quality improvements, and support audits and ISO 14971 compliance.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5+ years of experience in Post-Market Quality or a related medical device quality function.
• Experience working in FDA, EU MDR, and/or ISO 13485 regulated environments.
• Strong background in complaint investigations, CAPA, risk management (ISO 14971), and data analysis/trending.

Responsibilities

• Analyze and trend post-market quality and performance data.
• Identify emerging issues and support continuous improvement initiatives.
• Lead and support CAPA activities resulting from complaints, audits, and trending.
• Author post-market surveillance reports and PSURs.
• Evaluate complaints for reportability under FDA, EU MDR, and other global requirements.
• Conduct complaint investigations and root cause analysis.
• Support Health Hazard Evaluations (HHEs) and field action assessments.
• Participate in internal and external audits.
• Maintain risk management documentation in accordance with ISO 14971.

Skills

CAPA

Risk analysis

Data analysis

Regulatory compliance

Complaint investigations

Education

Bachelor's degree in Engineering

Job description

Real Staffing is assisting a medical device company in Burnsville, MN to hire a Senior Quality Engineer responsible for post-market surveillance, complaint handling, CAPA, risk management, and regulatory compliance across marketed products.

You will partner with Regulatory, Clinical, Operations and R&D teams to analyze data, investigate issues, drive quality improvements, and support audits and ISO 14971 compliance.