Senior Quality Design Assurance Engineer – Medical Devices

Heraeus Holding GmbH; Fridley (MN); On-site; USD 110,000 - 130,000; Full time

Job summary

Heraeus Medevio seeks a Senior Engineer in Quality Design Assurance to lead QA efforts on complex medical device development programs. The role includes design controls, risk management, verification/validation, and transfer to manufacturing to ensure robust, compliant products.

Onsite in Fridley, MN with possible moves to White Bear Lake, MN. You will mentor QA technicians, develop quarterly quality goals, and drive CAPA processes while collaborating across engineering, regulatory, and

Qualifications

• Bachelor degree in engineering required.
• 8+ years of relevant experience in medical device QA.
• Experience with ISO 13485, FDA QSR, GMP, ISO 14971.
• Willingness to travel between Fridley and White Bear Lake.

Responsibilities

• Serve as the primary QA engineer on complex product and process development projects with cross‑functional teams.
• Lead QA activities by creating quality plans, requirements traceability, and risk management plans.
• Review/approve change orders, deviations, verification/validation protocols, and IQ/OQ/PQ docs.
• Design/specify inspection plans and test procedures to meet specs and regulatory needs.
• Initiate, review and disposition nonconforming product; perform root-cause analysis and corrective actions.
• Support continuous improvement, CAPA, and quality system enhancements.
• Collaborate with engineering, manufacturing, regulatory, quality and operations to ensure QMS compliance.
• Facilitate customer and external audits (FDA/ISO) and mentor QA staff.

Skills

Quality Assurance

Design Controls

Risk Management

Verification & Validation

CAPA

Regulatory Compliance

Cross-functional collaboration

Documentation

Education

Bachelor degree in engineering

Master's degree in Engineering

Tools

Gages

Inspection tools

Test equipment

Minitab

Excel

Job description

Heraeus Medevio seeks a Senior Engineer in Quality Design Assurance to lead QA efforts on complex medical device development programs. The role includes design controls, risk management, verification/validation, and transfer to manufacturing to ensure robust, compliant products.

Onsite in Fridley, MN with possible moves to White Bear Lake, MN. You will mentor QA technicians, develop quarterly quality goals, and drive CAPA processes while collaborating across engineering, regulatory, and