Supplier Quality Engineer II
About The Position
This role supports Supplier Quality within Medtronic, partnering with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and sub-tier suppliers to ensure the quality, compliance, and continuous improvement of supplied medical devices and components. The team collaborates closely with Research & Development, Quality, Regulatory, and supplier partners to maintain effective quality systems, support product and process changes, and drive supplier performance across the product lifecycle. This is a U.S. Remote position. Candidates may be located anywhere within the United States but preference is the Midwest. Travel of up to 15% is required to support supplier visits, audits, business reviews, and cross-functional activities. The Supplier Quality Engineer II is responsible for managing supplier quality activities for Contract Manufacturers and Original Equipment Manufacturers, ensuring supplied products and processes meet Medtronic quality, regulatory, and customer requirements. This role partners with internal and external stakeholders to support product and process changes, monitor supplier performance, implement corrective actions, and drive continuous improvement across the supply base.
Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality
- Experience working within the medical device, pharmaceutical, biotechnology, or other highly regulated industry.
- 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.
- U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).
Nice To Haves
- Experience working with supplier quality systems, quality audits, corrective and preventive actions (CAPA), and change management processes.
- Experience supporting Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), or external supplier networks.
- Experience supporting regulated products within a quality-controlled manufacturing environment.
- Knowledge of root cause analysis methodologies and continuous improvement tools.
- Knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and risk management principles.
- Experience conducting supplier audits and leading supplier quality improvement initiatives.
- Certification as a Quality Engineer, Auditor, or related quality professional certification.
Responsibilities
- Manage supplier quality relationships with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and sub-tier suppliers to ensure compliance with quality and regulatory requirements.
- Support supplier-related product and process changes through effective quality planning, risk assessment, validation, and change control activities.
- Monitor supplier quality performance using established metrics and lead improvement initiatives to address quality, delivery, and compliance concerns.
- Conduct supplier audits, assessments, and business reviews to evaluate quality system effectiveness and identify opportunities for improvement.
- Investigate quality issues, facilitate root cause analysis, and drive corrective and preventive actions with suppliers and internal stakeholders.
- Partner with Research & Development, Quality, Regulatory, Operations, and Manufacturing teams to ensure supplied products meet finished device requirements.
- Review and approve supplier quality documentation, including nonconformance investigations, corrective actions, process validations, and change notifications.
- Ensure supplier activities comply with applicable medical device regulations, industry standards, and internal quality system requirements.
Benefits
- Competitive Salary
- Flexible Benefits Package
- 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
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Paid sick time (for temporary employees)
- Medtronic Incentive Plan (MIP)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
