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!
Support activities relating to the tactical deployment of the ZOLL Supplier Quality Management program. Assist the Procurement, Engineering, Quality Assurance and Manufacturing departments with the day to day issues relating to supplier quality, supplier certification and supplier process validation activities. Manage assigned projects to success. May have direct reports.
- Management and reporting of assigned projects related to New Product Introduction, costing improvements, quality improvements and/or pa11 resourcing activities.
- Validation activities of supplier processes including evaluation of 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. Suppliers may require mentoring in acceptable validation techniques
- Manages assigned suppliers thru the review of supplier performance metrics, communication of supplier performance to management and suppliers. Drive identified improvements in supplier's delivered quality. Completion of supplier improvement audits as needed. Travel may be required.
- Supports Engineering and Purchasing organizations with the identification, assessment and qualification of new vendors. Conducts Supplier Approval and Surveillance audits at new and existing suppliers.
- Daily quality support for disposition of non-conformances.
- Works independently or part of a team to conduct internal investigations for identified nonconformance's to root cause and implementation of corrective or preventative action.
- Up to 15% travel may be required.
Required/ Preferred Education and Experience:
- Ability to lead cross functional team projects, managing team resources and schedule to accomplish project goals.
- Working knowledge in one or more manufacturing processes: PCBA's, injection molding, formed metal, cables, electro-mechanical assembly's etc.
- CQE ASQ certification preferred.
- Familiarity with ISO13485, FDA 21 CFR Part 820 and GMP requirements.
- Working knowledge of Production, Documentation and Inventory Control systems (ORACLE/Agile experience preferre).
- Proficient in PC based applications (MS Word, Excel, PowerPoint, MS Project, Visio, Minitab etc.).
- Minimum of a Bachelor's Degree in Engineering or other technical discipline.
- Minimum 7 years' experience in a quality engineering role supporting medical device manufacturing with 2 years in a supplier quality support role.
- Direct experience in the improvement of supplier's quality and supplier auditing for continuous improvement. CQA ASQ certification preferred.
- Experience with Class II and Class Ill devices preferred.
Please note this job description is not designed to cover or contain a comprehensive listing ofactivities, duties, or responsibilities that are required of the employee for this job. Duties,responsibilities, and activities will be reviewed periodically as duties and responsibilities changewith business necessity. Essential and marginal job functions are subject to modification.ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
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