Supplier Quality Engineer II - Brooklyn Center, MN
About The Position
The Medtronic Energy and Component Center (MECC) provides critical manufacturing technologies, components, and operational support that help enable Medtronic therapies worldwide. MECC partners across product development, manufacturing, quality, and supplier networks to ensure the reliable supply of components and materials that meet customer, business, and regulatory requirements. The Supplier Quality Engineering function plays a key role in managing supplier performance, driving continuous improvement, supporting new product introduction, and ensuring compliance throughout the product lifecycle. This position is based in Brooklyn Center, Minnesota and requires onsite presence four (4) days per week. Limited travel up to 15% may be required to support supplier engagements, audits, and business needs. As a Supplier Quality Engineer II, you will lead supplier quality activities that ensure components and materials meet established quality, regulatory, and performance requirements. This role serves as a key liaison between suppliers and cross-functional teams, driving issue resolution, component qualification, quality improvement initiatives, and supplier change management to support reliable product supply and compliance.
Requirements
- Bachelor’s degree in Engineering, Science, or a technical field and 2+ years of engineering and/or quality experience; or an advanced degree in Engineering, Science, or a technical field with no prior engineering and/or quality experience required.
Nice To Haves
- Experience supporting quality systems, supplier quality, manufacturing quality, product quality, or engineering activities in a regulated or technical industry.
- Experience investigating nonconformances and implementing corrective actions using structured problem-solving methodologies.
- Ability to collaborate effectively with cross-functional teams and external suppliers to resolve technical and quality issues.
- Knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 requirements.
- Experience applying Lean Six Sigma or DMAIC methodologies; Green Belt or Black Belt certification preferred.
- Experience with statistical analysis techniques, including Statistical Process Control (SPC).
- Experience with risk management, CAPA, supplier quality systems, or supplier change management processes.
- Medical device industry experience, including component qualification, validation, or automated optical inspection validation.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Lead investigations and resolution of supplier-related quality and compliance issues identified during incoming inspection or manufacturing operations.
- Drive supplier corrective and preventive action (CAPA) activities, including root cause investigation, containment actions, effectiveness verification, and closure.
- Define and execute component qualification strategies, including Production Part Approval Process (PPAP) activities, qualification planning, and release readiness assessments.
- Evaluate and approve supplier change requests to ensure continued compliance with product, quality, and regulatory requirements.
- Partner with engineering, manufacturing, operations, and supplier teams to address product quality concerns and implement sustainable corrective actions.
- Develop and maintain supplier quality controls, acceptance strategies, control plans, and approved supplier documentation for existing and new products.
- Assess supplier performance through quality metrics, audits, and operational reviews, and provide recommendations for continuous improvement.
- Support internal and external audits, inspections, and regulatory activities, including preparation of records, responses, and corrective action plans.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
