Supplier Quality Engineer II

About the role

A Supplier Quality Engineer based in Irvine, CA supports 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.

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.
• Leads qualification and onboarding of new suppliers, including quality assessments, audits, and documentation review.
• Maintains monitoring of 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.
• Drives risk management activities related to supplied materials and processes.

Requirements

• Minimum Requirements: Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Nice to Have: Experience working within medical device or other highly regulated industries, familiarity with Medtronic quality systems, certification or formal training in Six Sigma, experience conducting supplier audits, experience with APQP, PPAP, or supplier qualification for new product introductions, knowledge of statistical analysis tools, experience with supplier corrective and preventive actions, experience supporting regulatory inspections or internal quality audits.

Qualifications

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Nice to Have: Experience working within medical device or other highly regulated industries, familiarity with Medtronic quality systems, certification or formal training in Six Sigma, experience conducting supplier audits, experience with APQP, PPAP, or supplier qualification for new product introductions, knowledge of statistical analysis tools, experience with supplier corrective and preventive actions, experience supporting regulatory inspections or internal quality audits.

Skills

• Technical drawing interpretation and GD&T knowledge.
• 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 leading cross-functional problem-solving teams using tools such as 8D or DMAIC.
• Exposure to design transfer or supplier transfer projects.
• Experience supporting risk management activities such as PFMEA/DFMEA related to supplier components.

Benefits

Competitive Salary and flexible Benefits Package including 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, and Simple Steps (global well-being program).