Senior Post-Market Quality Engineer - CAPA & Compliance

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

Job summary

Specialist Staffing Group is seeking a Senior Quality Engineer to support post-market surveillance, CAPA, risk management, and regulatory compliance for marketed medical devices in Burnsville, MN.

You will partner with Regulatory, Clinical, Operations and R&D teams to investigate issues, trend data, and drive continuous quality improvements while ensuring FDA, EU MDR, and ISO 13485 compliance.

Qualifications

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

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 Periodic Safety Update Reports (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

Post-Market Quality

CAPA

Risk Management

Data Analysis

Complaint Investigations

Regulatory Compliance

Communication

Education

Bachelor's degree in Engineering or related technical field

Job description

Specialist Staffing Group is seeking a Senior Quality Engineer to support post-market surveillance, CAPA, risk management, and regulatory compliance for marketed medical devices in Burnsville, MN.

You will partner with Regulatory, Clinical, Operations and R&D teams to investigate issues, trend data, and drive continuous quality improvements while ensuring FDA, EU MDR, and ISO 13485 compliance.