Senior Supplier Quality Engineer
About The Position
At Medtronic, we act boldly, compete to win, move with speed, foster belonging, and deliver results—the right way. This is the Medtronic Mindset, defining how we work and what we value. Our brand is rooted in action, and every team member plays a vital role in bringing our culture to life. We recognize your extraordinary potential to help ensure future generations live better, healthier lives. A career at Medtronic is purposeful, mission-driven, and unlike any other. We are committed to alleviating pain, restoring health, and extending life for millions worldwide. As a Supplier Quality Engineer based in Irvine, CA you will support the Neurovascular Operating Unit by ensuring externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. This role partners closely with Neurovascular R&D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, and resolve supplier-related nonconformances that could impact product performance or patient safety. You will lead investigations and root cause analysis for supplier issues, drive corrective and preventive actions with suppliers, and monitor performance through robust metrics and reviews. By building strong technical relationships with key suppliers and championing continuous improvement, this role helps maintain reliable supply and high first-time quality for Neurovascular products manufactured in Irvine, CA. Onsite: 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.
Requirements
- Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
- Possess unrestricted 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 medical device or highly regulated industries (FDA, ISO 13485, MDR, etc.)
- ASQ certifications such as Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or Certified Six Sigma Black/Green Belt
- Experience with supplier development and supplier performance improvement programs
- Demonstrated success in leading supplier audits (process, quality system, or compliance audits)
- Familiarity with risk management methodologies such as ISO 14971 and FMEA
- Experience supporting new product development (NPD) or design transfer to suppliers
- Strong background in advanced quality tools (SPC, MSA, DOE, capability analysis)
- Experience implementing or improving supplier corrective action (SCAR/CAPA) systems
- Experience working with contract manufacturers and global supply chains
- Exposure to manufacturing process validation (IQ/OQ/PQ) at supplier sites
- Experience with APQP, PPAP, and control plan development
- Familiarity with digital quality systems such as TrackWise, MasterControl, SAP, or similar QMS platforms
- Experience with component or process qualification for complex technologies (electronics, polymers, machining, sterile processing, etc.)
- Ability to analyze supplier quality metrics and drive continuous improvement initiatives
- Experience influencing suppliers and cross-functional teams without direct authority
- International supplier engagement experience or willingness to travel for supplier support and audits.
Responsibilities
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
- Lead qualification and onboarding of new suppliers, including quality assessments, audits, and documentation review.
- Support risk management activities related to supplied materials and processes.
- Partners with Site R&D, Quality, and Manufacturing Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
- Lead investigations for supplier-related nonconforming material and complaints; perform root cause analysis and implement sustainable corrective actions
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
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
