Director, Supplier Quality Engineering

ZOLL Medical
United States
Workplace: HybridFull timeUSD 190,000 - 210,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 10+ yearsEducation: bachelorsSkills: ["Strategic leadership","Coaching and mentoring","Cross-functional collaboration","Continuous improvement","Supplier development"]

Lead and develop the global Supplier Quality Engineering organization supporting manufacturing in the U.S. and China. Own supplier quality strategy and execution across inspections, nonconformances, SCARs, root-cause investigations, documentation, qualifications, and supplier change requests. Drive supplier performance improvements, scorecards, and initiatives to reduce Cost of Poor Quality. Support new product introductions and ensure regulatory compliance for medical devices (FDA QSR, ISO 13485, MDR, MDSAP), including audits and inspections.

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ZOLL Medical
ZOLL Medical
1 month ago

Director, Supplier Quality Engineering

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Last checked: 14 days agoStatus: Live

Job Summary

Lead and develop the global Supplier Quality Engineering organization supporting manufacturing in the U.S. and China. Own supplier quality strategy and execution across inspections, nonconformances, SCARs, root-cause investigations, documentation, qualifications, and supplier change requests. Drive supplier performance improvements, scorecards, and initiatives to reduce Cost of Poor Quality. Support new product introductions and ensure regulatory compliance for medical devices (FDA QSR, ISO 13485, MDR, MDSAP), including audits and inspections.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Director level

Key Responsibilities

  • •Lead and develop the global Supplier Quality organization supporting manufacturing sites in the U.S. and China.
  • •Establish the vision, strategy, and roadmap for Supplier Quality Management and define/report performance metrics.
  • •Resolve incoming inspection issues and supplier nonconformances; lead SCARs and root cause investigations.
  • •Oversee supplier documentation, qualification, validations, and supplier change requests; escalate and resolve issues affecting production.
  • •Ensure compliance with FDA QSR, ISO 13485, MDR, and MDSAP; support supplier selection/qualification for NPIs, audits, and regulatory inspections.

Pay and Benefits

Salary: USD 190,000 - 210,000 annually

Key Requirements

  • •Bachelor’s degree in Engineering, Quality, Supply Chain, or related field; Master’s preferred.
  • •10+ years in Supplier Quality/Quality Engineering in regulated manufacturing.
  • •5+ years leading Supplier Quality organizations.
  • •Experience with complex electromechanical products, global suppliers, and medical devices (preferred).
  • •Ability to establish and execute supplier quality strategy, processes, and organizational capabilities.
Experience:10+ yearsRegulated manufacturingMedical devicesElectromechanical products
Education:Bachelor's in Engineering, Quality, Supply Chain, or related field
Skills:Strategic leadershipCoaching and mentoringCross-functional collaborationContinuous improvementSupplier development

Company Brief

ZOLL Medical
Designs and manufactures medical devices and software for critical care and rescue, including defibrillators, ventilators, CPR feedback systems, and monitoring solutions for hospitals, emergency responders, and public access settings.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Growth: Established Company
Headquarters: Chelmsford, United States
Founded: 1980
WebsiteLinkedIn