Quality Engineer II – Medical Devices & CAPA

Medtronic; Minnesota; On-site; USD 79,000 - 119,000; Full time

Job summary

Medtronic in Minnesota is seeking a Quality Engineer II to support the Service & Repair quality organization. This onsite role requires collaboration across Engineering, Regulatory, and Supplier Quality to maintain compliance and drive CAPA and process improvements.

The candidate will handle validation activities, supplier quality oversight, and change control, with travel around 15% and a five-day onsite presence to support manufacturing and service operations.

Qualifications

• Bachelor’s degree in Engineering, Science or technical field with 2+ years of engineering/quality experience.
• Advanced degree with 0+ years of engineering/quality experience acceptable.
• Experience in a regulated medical device environment preferred.

Responsibilities

• Partner with cross-functional teams to ensure quality system compliance and operational objectives.
• Develop, implement, and maintain quality standards, procedures, and controls.
• Provide oversight for validation, verification, nonconformance, and CAPA processes.
• Investigate quality issues, assess risk, and support corrective actions.
• Ensure suppliers deliver quality parts, materials, and services.
• Coordinate change control with review and approval for regulatory compliance.
• Review test plans and reports for change and supplier-related activities.
• Conduct supplier audits and ensure GMP/ISO compliance.

Skills

Quality engineering

CAPA

Audits

Education

Bachelor’s Degree in Engineering/Science

Advanced Degree in Engineering/Science

Tools

PPAP

Job description

Medtronic in Minnesota is seeking a Quality Engineer II to support the Service & Repair quality organization. This onsite role requires collaboration across Engineering, Regulatory, and Supplier Quality to maintain compliance and drive CAPA and process improvements.

The candidate will handle validation activities, supplier quality oversight, and change control, with travel around 15% and a five-day onsite presence to support manufacturing and service operations.