Supplier Quality Engineer II
About The Position
The Supplier Quality Engineering team within Cranial and Spinal Technologies (CST) supports the Spine & Biologics product portfolio through supplier quality management, supplier change control, and released product support activities. This team partners with suppliers and cross-functional stakeholders to maintain product quality, regulatory compliance, and supply continuity throughout the product lifecycle. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Supplier Quality Engineer partners with suppliers and internal stakeholders to ensure quality, compliance, and continuity of supply for released products. This role is responsible for supplier performance monitoring, supplier qualification activities, audit execution, change management, and resolution of supplier-related quality issues that impact manufacturing and product availability.
Requirements
- Bachelor's degree and 2+ years of relevant experience OR Master's degree and 0+ years of relevant experience.
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- Experience in the medical device, pharmaceutical, biotechnology, or other regulated industry.
- Experience conducting supplier audits and supplier qualification activities.
- Experience with supplier change management, product qualification, and risk assessment processes.
- Experience with receiving inspection, acceptance sampling, and test method validation.
- Knowledge of ISO 13485, Quality System Regulation (QSR), or other applicable regulatory requirements.
Responsibilities
- Ensure suppliers consistently deliver quality parts, materials, and services for released products.
- Qualify and maintain suppliers in accordance with Medtronic quality requirements and approved supplier processes.
- Lead supplier change qualification activities and execute documentation required for timely implementation.
- Investigate, communicate, and resolve supplier-related quality issues to minimize manufacturing and supply chain impact.
- Develop and execute supplier audit plans to assess compliance with Good Manufacturing Practices (GMP) and quality system requirements.
- Evaluate supplier quality systems and operational performance and provide feedback to drive continuous improvement.
- Partner with Component Engineering and cross-functional teams to develop acceptance sampling strategies, control plans, and supplier quality requirements.
- Participate in Engineering Review Board (ERB) activities and support disposition of nonconforming materials.
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
