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Supplier Quality Engineer II
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-06-20
Listing for:
Medtronic
Full Time
position Listed on 2026-06-20
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
Application Window
We anticipate the application window for this opening will close on - 22 Jun 2026.
OverviewAt Medtronic you can begin a life‑long career of exploration and innovation while helping champion healthcare access and equity for all.
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.
- Provide Pre‑Market Quality Engineering support to New Product Development and deliver quality parts, materials, and services to prevent defects.
- Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Partner 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.
- Collaborate 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 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.
Minimum Requirements
- Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR a Master’s degree with a minimum of 0 years relevant experience.
- 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.
Job Requirements
The above statements describe the general nature and level of work performed by employees assigned to this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
U.S. Work Authorization & SponsorshipRoles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & CompensationSalary…
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