Senior Supplier Quality Engineer
About The Position
The Supplier Quality function partners with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and critical suppliers to ensure the quality, compliance, and performance of externally manufactured products and components. This team works cross-functionally with Research & Development (R&D), Quality, Regulatory Affairs, and Operations to support product lifecycle activities, drive supplier performance improvements, and maintain compliance with applicable quality system and regulatory requirements. This position may be performed remotely anywhere within the United States. Travel up to 15% is required to support supplier audits, supplier performance reviews, business meetings, and cross-functional initiatives. The Senior Supplier Quality Engineer serves as the primary quality partner for strategic Contract Manufacturers and Original Equipment Manufacturers, ensuring supplier processes, products, and quality systems consistently meet Medtronic requirements. This role drives supplier quality performance, supports product and process changes, leads quality improvement initiatives, and provides technical quality guidance across supplier-related activities throughout the product lifecycle.
Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.
- 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.
Nice To Haves
- Experience working with supplier quality systems, supplier qualification, supplier audits, or supplier performance management.
- Experience supporting quality processes within a regulated industry environment.
- Experience interpreting and applying quality system requirements, technical documentation, specifications, and quality standards.
- Experience supporting Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), or external manufacturing partners within the medical device industry.
- Experience with New Product Development (NPD), product transfers, process validation, design transfer, or supplier onboarding activities.
- Lead Auditor or certified quality-related credential such as American Society for Quality (ASQ) certification.
- Knowledge of ISO 13485, 21 CFR Part 820, Good Manufacturing Practices (GMP), and global medical device regulatory requirements.
- Experience leading supplier corrective actions, continuous improvement initiatives, and cross-functional quality projects.
Responsibilities
- Manage quality oversight of strategic Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and designated suppliers to ensure compliance with product, process, and quality system requirements.
- Lead supplier quality activities associated with product and process changes, including risk assessment, qualification, validation, and implementation support.
- Monitor supplier performance metrics, identify quality risks and trends, and drive corrective and preventive actions to improve supplier effectiveness and product quality.
- Plan, conduct, and support supplier audits to assess compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements.
- Partner with Research & Development (R&D), Regulatory Affairs, Operations, and Quality teams to ensure supplied products and components meet finished device requirements.
- Investigate supplier-related nonconformances, complaints, and quality issues, facilitating root cause analysis and sustainable corrective actions.
- Provide Supplier Quality support for New Product Development (NPD) activities, including supplier qualification, product acceptance strategies, control plans, and supplier quality deliverables.
- Define and maintain receiving inspection requirements, supplier controls, and quality documentation necessary to support product acceptance and compliance.
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
Senior
