Principal Supplier Quality Engineer

Medtronic

Principal Supplier Quality Engineer managing strategic Contract Manufacturers and OEMs at Medtronic. Responsible for product quality assurance and compliance with industry standards and regulations.

Posted 5/20/2026full-timeRemote • California, Massachusetts, Minnesota • 🇺🇸 United StatesLead💰 $123,200 - $184,800 per yearWebsite

About the role

Key responsibilities & impact

Ensure that suppliers deliver quality parts, materials, and services.
Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation.
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.
Provide 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.
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 as required and associated test method validation for all internal Medtronic Test Methods.

Requirements

What you’ll need

Bachelor’s Degree in Engineering, Science or technical field with 7 years of work experience in Engineering and/or Quality
Advanced degree in Engineering, Science or technical field with 5 years of work experience in Engineering and/or Quality
PhD with 3 years of work experience in Engineering and/or Quality
Experience supporting external contract manufacturers for finished medical devices, including oversight of supplier quality agreements, performance monitoring, and issue escalation.
Advanced knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and familiarity with global regulatory expectations.
Demonstrated experience leading complex supplier investigations, including root cause analysis, CAPA development, and implementation of corrective actions across multi-site supply chains.
Prior experience performing and leading supplier audits (onsite and remote), including certification as a lead auditor or equivalent training.
Experience implementing or reviewing Production Part Approval Process (PPAP) packages with suppliers or contract manufacturers, including evaluation of control plans, PFMEA, MSA, capability studies, and first article inspection results to support production readiness.
Certification or formal training in continuous improvement methodologies such as Lean, Six Sigma (Green Belt or higher), FTQ, or similar process improvement frameworks, with demonstrated application in supplier or manufacturing environments.
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.

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality engineeringsupplier quality managementroot cause analysisCAPA developmentProduction Part Approval Process (PPAP)control plansPFMEAMSAfirst article inspectionauditing

Soft Skills

communicationcollaborationproblem-solvingleadershipfeedback provisiontechnical guidanceprioritizationcontinuous improvement

Certifications

LeanSix Sigma (Green Belt or higher)lead auditor certification