Senior Quality Design Assurance Engineer (Medical Devices)

Real Staffing; Saint Paul (MN); On-site; USD 110,000 - 130,000; Full time

Job summary

Real Staffing is seeking a Senior Quality Design Assurance Engineer to lead QA on complex medical device product development projects in Fridley, MN. The role focuses on design controls, risk management, verification, validation, and design transfer to manufacturing.

The ideal candidate has 8+ years in quality/engineering within medical devices, strong problem-solving, and familiarity with QMS, ISO 13485, and FDA requirements. Onsite work with occasional travel to local facilities in Minnesota.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum of 8 years of relevant engineering or quality experience.
• Experience in the medical device industry, preferably within a Quality Assurance role.
• Knowledge of quality inspection methods, measurement systems, and test equipment.
• Strong problem-solving and root cause analysis skills.
• Proficiency with Microsoft Office applications and Minitab.
• Ability to travel between local Minnesota facilities as needed.

Responsibilities

• Serve as the lead Quality Assurance Engineer on complex product and process development projects.
• Partner with cross-functional teams to drive project deliverables through established product development processes.
• Develop and maintain Quality Plans, Risk Management Plans, and requirements traceability documentation.
• Review and approve quality-related documentation including change orders, deviations, validation protocols, qualification reports, and inspection procedures.
• Design and implement inspection strategies, test plans, procedures, and quality systems to ensure compliance with specifications and regulatory requirements.
• Lead investigations of nonconforming products, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Monitor quality metrics, trends, and complaint data to identify opportunities for improvement.
• Support continuous improvement initiatives focused on product quality, manufacturability, and process robustness.
• Collaborate with engineering, manufacturing, regulatory affairs, and operations teams to ensure ongoing QMS compliance.
• Support customer audits and external inspections, including FDA and ISO audits.
• Mentor junior quality professionals and provide technical guidance to team members.
• Contribute to quality objectives, management reviews, training activities, and organizational improvement initiatives.

Skills

Quality Assurance

Design Controls

Risk Management

Minitab

MS Office

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Measurement equipment

Quality management software (QMS)

Job description

Real Staffing is seeking a Senior Quality Design Assurance Engineer to lead QA on complex medical device product development projects in Fridley, MN. The role focuses on design controls, risk management, verification, validation, and design transfer to manufacturing.

The ideal candidate has 8+ years in quality/engineering within medical devices, strong problem-solving, and familiarity with QMS, ISO 13485, and FDA requirements. Onsite work with occasional travel to local facilities in Minnesota.