Senior Supplier Quality Engineer

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Position Description: Support activities relating to the tactical deployment of the ZOLL Supplier Quality Management program. Assist the procurement, Engineering, Quality Assurance and Manufacturing departments with daily issues pertaining to supplier quality, supplier certification and supplier process validation activities. Manage and provide reports for New Product Introduction, cost improvements, quality improvements and/or pa11 resourcing activities. Evaluate supplier validation plans to include: PFMEA, Control Plans, Capability Studies, IQ and OQ, PQ. Collect, review and summarize validation objective evidence and issue supplier CAPA as appropriate. Mentor suppliers in acceptable validation techniques. Review supplier performance metrics and communicate performance to management. Drive identified improvements in supplier quality. Perform supplier improvement audits as needed. Support engineering and purchasing organizations with identification, assessment and qualification of new vendors. Conduct Supplier Approval and Surveillance audits for new and existing suppliers. Provide daily quality support for disposition of non-conformances. Conduct internal investigations with regards to non-conformance: Identify root cause and implement corrective or preventative action.

Required Experience/Skills: Requires a Bachelor’s degree (or foreign equivalent) in Industrial or Biomedical Engineering plus seven (7) years of quality engineering experience supporting medical device manufacturer. Will accept Master’s degree plus four (4) years of described experience. Experience must include:

Four (4) years of experience in the following (experience may be gained concurrently):

• Dispositioning non-conforming material
• Formed Metal
• Production, Documentation and Inventory Control systems

Two (2) years of experience in each of the following (experience may be gained concurrently):

• Supplier Auditing
• PCBA (Printed Circuit Board Assembly)
• Manage team resources and schedules
• Leading cross functional team projects
• Supplier Quality Engineering role
• ISO13485
• Cables
• FDA 21 CFR Part 820 and GMP requirement
• Electromechanical Assembly

Location: 269 Mill Rd., Chelmsford, MA 01824