Lead Supplier Quality Engineer (Medical Devices)

Regulatory Jobs; Mounds View (MN); On-site; USD 123,000 - 185,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k) plan

Job summary

Medtronic in the United States is seeking a Principal Supplier Quality Engineer to lead supplier transfers and QA activities across design transfer, manufacturing readiness, supplier qualification, and process improvement.

The role partners with suppliers and cross-functional teams to establish qualification and product acceptance strategies, execute validations, assess performance, and ensure compliance with quality and regulatory requirements.

Qualifications

• Education: Bachelor's in Engineering/Science/Technical field with 7+ years experience.
• Advanced degrees: Master's with 5+ years or PhD with 3+ years.

Responsibilities

• Define component qualification strategies using PPAP methodologies and establish supplier qualification plans, performance measures, and release readiness criteria.
• Execute product and component qualification activities to ensure suppliers are capable of delivering conforming products and materials.
• Lead Supplier Quality activities throughout the product lifecycle and provide technical guidance on supplier quality and compliance requirements.
• Develop and execute product acceptance strategies, supplier control plans, sampling strategies, and test method validations.
• Review and approve Engineering Change Notices, test methods, test equipment, and other quality deliverables for supplier transfers and manufacturing readiness.
• Evaluate supplier processes and quality systems, identify performance gaps, and provide feedback to improve supplier performance.
• Coordinate Approved Supplier List activities and Supplier Owned Quality deployment for transferred products.
• Analyze and communicate supplier quality indicators and performance data to support cross-functional decisions.

Skills

Supplier Quality

PPAP

Quality Assurance

Regulatory compliance

Education

Bachelor's degree in Engineering/Science/Technical field

Master's degree

PhD

Tools

Windchill

Minitab

GD&T software

Job description

Medtronic in the United States is seeking a Principal Supplier Quality Engineer to lead supplier transfers and QA activities across design transfer, manufacturing readiness, supplier qualification, and process improvement.

The role partners with suppliers and cross-functional teams to establish qualification and product acceptance strategies, execute validations, assess performance, and ensure compliance with quality and regulatory requirements.