Senior Quality Post Market Engineer

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

Location: Burnsville, MN
Compensation: $110,000 - $132,000 base salary + comprehensive benefits

About the Role

A medical device company is seeking a Senior Quality Engineer to support post-market surveillance, complaint handling, CAPA, risk management, and regulatory compliance activities for marketed products. This role partners closely with Regulatory, Clinical, Operations, and R&D teams to evaluate product performance, identify trends, investigate issues, and drive quality improvements.

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.

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.
• Excellent written and verbal communication skills.

This is an opportunity to play a key role in product safety, regulatory compliance, and continuous quality improvement within a growing medical device organization.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.