Senior Supplier Quality Engineer - Medical Devices

Regulatory Jobs; Mounds View (MN); On-site; USD 99,000 - 149,000; Full time

Benefits offered by this job

Health, Dental & Vision insurance

401(k) with company match

Tuition assistance

Job summary

Medtronic, a global leader in healthcare technology, is seeking a Senior Supplier Quality Engineer in the United States. You will support supplier transfers, qualification activities, and product lifecycle quality, partnering with suppliers and cross-functional teams to ensure compliance with quality requirements throughout design transfer and manufacturing.

The role requires onsite work in multiple U.S. locations and periodic travel.

Qualifications

• Bachelor’s degree in Engineering, Science, or technical field with 4+ years in a regulated industry or advanced degree with 2+ years, or PhD.
• Experience with supplier controls, ASL, PPAP, product qualification and supplier quality activities.
• Knowledge of FDA regulations and ISO standards for medical devices.

Responsibilities

• Define qualification strategies including PPAP, plans, control plans, and release readiness.
• Lead supplier product qualification to ensure conforming deliveries.
• Provide engineering guidance and compliance oversight across product lifecycle.
• Develop acceptance strategies, sampling plans, and test method validation at suppliers.
• Evaluate supplier processes, identify risks, and drive improvements.

Skills

Supplier quality

PPAP

QA methods

Minitab

FDA/ISO

Windchill/PLM

Education

Bachelor's degree in Engineering/Science

Advanced degree / PhD (optional)

Tools

Windchill

Agile PLM

Minitab

Job description

Medtronic, a global leader in healthcare technology, is seeking a Senior Supplier Quality Engineer in the United States. You will support supplier transfers, qualification activities, and product lifecycle quality, partnering with suppliers and cross-functional teams to ensure compliance with quality requirements throughout design transfer and manufacturing.

The role requires onsite work in multiple U.S. locations and periodic travel.