Director, Supplier Quality Engineering

Posted 24 Days Ago
Be an Early Applicant
Chelmsford, MA, USA
In-Office
190K-210K Annually
Expert/Leader
Healthtech • Software
The Role
Lead global Supplier Quality Engineering for electromechanical medical devices, ensuring supplier qualification, regulatory compliance (FDA QSR, ISO 13485, MDR, MDSAP), SCAR resolution, supplier performance improvement, NPI supplier support, audits, and reduction of supplier-related COPQ while building a high-performing team.
Summary Generated by Built In
Acute Care Technology

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose.
Join our team. It’s a great time to be a part of ZOLL!

Due to the on‑site requirements of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (Chelmsford, MA).

ZOLL Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future.

Job Summary

The Director of Supplier Quality Engineering reports to the Vice President of Procurement and provides strategic and operational leadership for the Supplier Quality Engineering organization supporting manufacturing operations in the United States and China. This role is responsible for ensuring supplier quality, supplier parts validations, regulatory compliance, and supplier performance across a global, multi-tier supply chain supporting complex electromechanical medical devices.
The Director partners closely with Sourcing, R&D, Quality Assurance, Regulatory Affairs, Operations, and Manufacturing Engineering to ensure suppliers consistently meet quality, delivery, and compliance requirements. The position oversees both day-to-day supplier quality activities and the development of long-term supplier quality strategies, processes, and organizational capabilities that improve supplier performance, reduce risk, and lower the Cost of Poor Quality (COPQ) at suppliers.

Key ResponsibilitiesLeadership
  • 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.

  • Build organizational capabilities, develop talent, and create succession plans.

  • Define and report performance metrics and drive continuous improvement.

Operational Supplier Quality
  • 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 supplier issues affecting production.

Supplier Performance & Continuous Improvement
  • Develop supplier scorecards and business reviews.

  • Drive supplier development initiatives.

  • Establish processes to reduce supplier-related COPQ.

  • Partner with Procurement to improve supplier performance and mitigate risk.

New Product Introduction & Regulatory Compliance
  • Support supplier selection and qualification for NPIs.

  • Partner with R&D and Engineering on product launches and engineering changes.

  • Ensure compliance with FDA QSR, ISO 13485, MDR, and MDSAP.

  • Support supplier audits and regulatory inspections.

Qualifications
  • 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.

Leadership Competencies
  • Strategic leadership

  • Coaching and Mentoring

  • Supplier quality systems

  • Cross-functional collaboration

  • Continuous improvement

  • Supplier development

  • Regulatory expertise

Success Measures
  • Improved supplier quality performance

  • Reduced COPQ

  • Timely SCAR closure

  • Strong audit performance

  • Successful NPI support

  • Reduced production disruptions

  • High-performing Supplier Quality organization

  • Deliver value beyond the supplier quality organization

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

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The annual salary for this position is:

$190,000.00 to $210,000.00

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

Skills Required

  • Bachelor's degree in Engineering, Quality, Supply Chain, or related field
  • Master's degree (preferred)
  • 10+ years in Supplier Quality/Quality Engineering in regulated manufacturing
  • 5+ years leading Supplier Quality organizations
  • Experience ensuring compliance with FDA QSR, ISO 13485, MDR, and MDSAP
  • Experience supporting supplier audits and regulatory inspections
  • Experience with complex electromechanical products, global suppliers, and medical devices
  • Reside within reasonable commuting distance of Chelmsford, MA (on-site requirement)
  • Must not require immigration-related sponsorship

ZOLL Medical Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ZOLL Medical Corporation and has not been reviewed or approved by ZOLL Medical Corporation.

  • Healthcare Strength Medical, dental, and vision coverage includes in‑network preventive care at 100% along with behavioral health/EAP and virtual therapy options. These features are often regarded as solid to good components of the package.
  • Parental & Family Support Paid parental leave provides 12 weeks at full pay for the birthing parent and 6 weeks for the non‑birthing parent after eligibility is met. This policy is frequently highlighted as a standout element.
  • Wellbeing & Lifestyle Benefits Wellness programs offer incentives and are complemented by multiple external well‑being recognitions. These programs add perceived value to total rewards.

ZOLL Medical Corporation Insights

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The Company
HQ: Chelmsford, MA
30,000 Employees

What We Do

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries.

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