Supplier Quality Engineer II

Medtronic•Toledo, OH

5d•$80,000 - $120,000•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life 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 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

Experience working within medical device or other highly regulated industries (e.g., FDA, ISO 13485, GMP environments).
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 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.

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.
Lead qualification and onboarding of new suppliers, including quality assessments, audits, and documentation review.
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.
Support risk management activities related to supplied materials and processes.
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.
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.
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 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 (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)