Supplier Quality Engineer II

Medtronic

Supplier Quality Engineer II at Medtronic ensuring quality of supplier-provided materials. Leading supplier qualification and audit plans, collaborating across teams to improve outcomes.

Posted 6/13/2026full-timeBoxborough • Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $80,000 - $120,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

supplier qualificationsupplier auditssupplier developmentsupplier performance managementquality management systemsFDA Quality System RegulationsISO 13485Good Manufacturing PracticesNew Product Developmentquality engineering tools

Soft Skills

communicationcollaborationproblem-solvingfeedbackcontinuous improvement

Tools & Technologies

CAPAroot cause analysisstatistical techniquesFMEAcontrol plan development

Certifications & Qualifications

ASQ certificationCQECSQPLean Six Sigma Green BeltLean Six Sigma Black Belt

Industry Keywords

regulated industrydesign controlsrisk managementprocess validationsupplier quality systems

About the role

Key responsibilities & impact

Ensure suppliers consistently deliver high-quality parts, materials, and services that meet Medtronic requirements.
Qualify and approve suppliers in accordance with company standards and support supplier certification programs to drive quality and cost-effectiveness.
Monitor supplier performance from sourcing through manufacturing, proactively identifying, communicating, and resolving supplier-related quality issues.
Develop, prioritize, and execute supplier audit schedules to ensure compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements.
Assess suppliers’ quality systems, manufacturing processes, and operational performance, providing feedback and recommendations for continuous improvement.
Provide Supplier Quality Engineering support for New Product Development (NPD) projects, partnering with Component Engineering and Post-Market Supplier Quality teams to ensure robust supplier selection and qualification.
Drive quality planning and compliance activities throughout the NPD lifecycle, ensuring purchased materials and components meet applicable industry standards, regulatory requirements, and customer expectations.
Collaborate with Component Engineers to develop product acceptance sampling strategies, manage Approved Supplier List (ASL) activities, deploy Supplier-Owned Quality initiatives, and establish control plans for new products.
Define Receiving Inspection requirements and support validation of internal Medtronic test methods used to verify supplier-provided components and materials.
Implement strategies that prevent defects, improve supplier performance, and support the delivery of safe, reliable, and high-quality products to customers.

Requirements

What you’ll need

Bachelors degree in Engineering or Technical field with minimum of 2 years of relevant experience, OR Advance degree in Engineering or Technical field with minimum of 0 years of relevant experience
Experience supporting supplier qualification, supplier audits, supplier development, and supplier performance management within a regulated industry
Knowledge of quality management systems and applicable regulatory requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP)
Experience supporting New Product Development (NPD) activities, including Design Controls, risk management, process validation, and control plan development
Proficiency in quality engineering tools and methodologies, including CAPA, root cause analysis, statistical techniques, FMEA, and continuous improvement practices
Experience conducting supplier assessments and audits, with the ability to evaluate supplier quality systems and drive corrective actions
ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green Belt or Black Belt certification preferred.
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
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