Senior Supplier Quality Engineer

Supplier Quality Engineer – Neurovascular Operating Unit

Location: Irvine, CA (minimum 5 days onsite)

Ensure externally sourced materials, components, and services consistently meet Medtronic quality and regulatory requirements. Partner 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.

• Qualify suppliers according to company standards and administer Certified Supplier Program inspections for cost effectiveness.
• Monitor parts from acquisition through manufacturing cycle, communicating and resolving supplier‑related problems.
• Evaluate suppliers' internal functions for overall performance and provide feedback.
• Provide Pre‑Market Quality Engineering support to New Product Development (NPD) and Partner with Component Engineers to develop product acceptance sampling strategies, approved supplier lists, supplier‑owned quality deployment, and control plans for new products.
• Define Receiving Inspection requirements and validate test methods 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.
• Assist in developing test methods, equipment acquisition, validations/qualifications, and statistical analysis of data for quality objectives.
• Lead investigations for supplier‑related nonconforming material and complaints, perform root‑cause analysis, and implement sustainable corrective actions.

• Baccalaureate degree plus minimum 4 years of relevant experience, or Master’s degree plus minimum 2 years, or PhD with no required experience.
• Experience working with medical device or highly regulated industries (FDA, ISO 13485, MDR, etc.).
• ASQ certifications such as CQE, CSQP, or Six Sigma Black/Green Belt.
• 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 NPD or design transfer to suppliers.
• Background in advanced quality tools (SPC, MSA, DOE, capability analysis).
• Experience implementing or improving supplier corrective action (SCAR/CAPA) systems.
• Experience 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 Track Wise, Master Control, 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.
• For Baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

• In-depth medical device regulatory knowledge (FDA, ISO 13485, MDR).
• Advanced statistical and data‑analysis skills.
• Experience in supply chain optimization and lean manufacturing techniques.

The above statements describe the general nature and level of work performed. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Salary range for U.S. (excl. PR) locations: $99,200.00 – $. Eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). Additional benefits include:

• Health, Dental and Vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long‑term disability leave
• Dependent daycare spending account
• Tuition…