Supplier Quality Engineer II: GMP Audits & Supplier Quality

Medtronic plc; Brooklyn Park (MN); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with match

Tuition assistance

Job summary

Medtronic plc is seeking a Supplier Quality Engineer to ensure supplier parts meet quality standards and support GMP-compliant audits across the manufacturing lifecycle.

Responsibilities include supplier qualification, inbound inspection collaboration, and developing audit schedules. Preferred candidates bring DMAIC/Lean Six Sigma exposure and experience with ISO 13485, 21 CFR 820, and CAPA processes.

Qualifications

• Bachelor’s degree in Engineering, Science or technical field with 2+ years of relevant experience; OR Master’s degree with 0+ years of relevant experience.
• Strong educational background aligned with medical device quality requirements.

Responsibilities

• Ensure suppliers deliver parts, materials, and services that meet established quality requirements.
• Qualify suppliers according to company standards and support receiving inspection and supplier quality programs.
• Monitor supplier parts throughout the manufacturing cycle and drive resolution of supplier-related quality issues.
• Develop and prioritize supplier audit schedules and conduct audits against GMP and applicable quality standards.
• Evaluate supplier processes and quality systems, communicate findings, and drive improvements.
• Provide Supplier Quality Engineering support throughout the New Product Development lifecycle for newly qualified parts.
• Partner with Component Engineering and Post-Market Supplier Quality teams on acceptance sampling strategies, ASL coordination, Supplier Owned Quality deployment, and control plans.
• Define receiving inspection requirements and support validation of applicable internal test methods.

Education

Bachelor’s or Master’s degree in Engineering/Science/technical field

Job description

Medtronic plc is seeking a Supplier Quality Engineer to ensure supplier parts meet quality standards and support GMP-compliant audits across the manufacturing lifecycle.

Responsibilities include supplier qualification, inbound inspection collaboration, and developing audit schedules. Preferred candidates bring DMAIC/Lean Six Sigma exposure and experience with ISO 13485, 21 CFR 820, and CAPA processes.