Supplier Quality Engineer II

Supplier Quality Engineer – Irvine, CA

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.

You will partner closely with Neurovascular R&D, Manufacturing, Operations Quality, and Sourcing to qualify and develop suppliers, support new product introductions and design changes, resolve supplier‑related nonconformances that could impact product performance or patient safety, and drive continuous improvement across the supply chain.

• Qualify and onboard new suppliers through quality assessments, audits, and documentation review.
• Ensure suppliers deliver quality parts, materials, and services and administer a Certified Supplier Program as needed.
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier‑related problems.
• Evaluate suppliers’ internal functions to assess overall performance and provide feedback.
• Support risk management activities related to supplied materials and processes.
• Provide Pre‑Market Quality Engineering support to New Product Development, including test method development and validation.
• Collaborate with Site R&D, Quality, and Manufacturing Engineering to develop test methods, equipment acquisition, and statistical analysis of data.
• Develop and deliver Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements and validate associated test methods.
• Lead investigations for supplier‑related nonconforming material and complaints, perform root cause analysis and implement sustainable corrective actions.

• Baccalaureate degree and minimum 2 years of relevant experience, or Master’s degree with 0 years of experience.
• Experience working within medical device or other highly regulated industries (e.g., FDA, ISO 13485, GMP).
• Familiarity with Medtronic quality systems, SAP, or similar enterprise quality management systems.
• Certification or formal training in Six Sigma (Green Belt or higher), Lean Manufacturing, or Continuous Improvement methodologies.
• Experience conducting supplier audits, including ISO 13485 or MDSAP audit participation.
• Demonstrated experience with Advanced Product Quality Planning (APQP), PPAP, or supplier qualification for new product introductions.
• Knowledge of statistical analysis tools such as Minitab, JMP, or similar software for quality data analysis.
• Experience driving supplier corrective and preventive actions (SCAR/CAPA) and closing systemic issues with suppliers.
• Background working with global suppliers and cross‑regional teams.
• Experience supporting risk management activities such as PFMEA/DFMEA related to supplier components.
• Exposure to design transfer or supplier transfer projects.
• Strong technical drawing interpretation and GD&T knowledge.
• Experience with incoming inspection strategies, sampling plans (ANSI/ASQ Z1.4), or inspection optimization.
• Demonstrated ability to lead cross‑functional problem‑solving teams using tools such as 8D or DMAIC.
• Prior experience supporting regulatory inspections or internal quality audits.
• For alumni of non‑U.S. institutions, a degree satisfying 8C.F.R. §214.2(h)(4)(iii)(A) is required.

Regular independent mobility and frequent computer use are required. Reasonable accommodations may be made for individuals with disabilities.

We are an equal opportunity employer and provide reasonable accommodations to qualified individuals with disabilities. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity, or any other characteristic protected by law.