Supplier Quality Engineer

Location: Deerfield, WI

Resuscitation

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!

Job Summary:

Support activities relating to the management of ZOLL's Supplier Engineering Quality Management Program. Assist the Procurement, Quality Assurance, Manufacturing and Engineering departments with the day to day issues relating to Supplier certification, validation and Quality. Pursue continuous process and yield improvement throughout ZOLL's Supplier base.

Essential Functions:

  • Manages assigned Suppliers through the review of Supplier performance data, communication of Supplier performance with Supplier, driving improvements in Supplier's delivered Quality, evaluation and validation of Supplier proposed changes and completion of Supplier improvement or qualification audits as needed.

  • Daily Quality support for issues arising in incoming inspection, MRB and on the production lines.

  • Supports the New Product Introduction, Cost Reduction, and part resourcing activities through the completion of Supplier outsource validations of ZOLL designed parts/assemblies.

  • Collect, review, summarize validation objective evidence, write validation reports and issue Supplier corrective actions as appropriate.

  • Works independently and as part of a team to conduct internal investigations for identified nonconformance's to root cause and implementation of corrective or preventative action.

  • Supports the R&D, component and purchasing organizations with the identification and selection of vendors in the new product development process.

  • Other duties as required, to include internal process improvements.

  • Some travel will be required.

Skills Requirements:

  • Working knowledge of manufacturing processes (PCB fabrication, PCBA and Cable assembly, injection molding, machining, etc.) desired.

  • Knowledge of development and execution of validation strategies including IQ, OQ, PQ

  • Quality tools such as documentation review, process flow maps, control charts and PFMEA both at ZOLL and the Supplier base.

  • Background in product structure, BOMs and MRP systems.

  • Background with ISO13485, IS09001, FDA 21 CFR Part 820.

  • Excellent organizational skills and proven ability to effectively prioritize initiatives to meet expectations

  • Demonstrated proficiency in Microsoft Office applications, particularly Excel

  • Proficiency with Agile document management system desired.

  • Excellent time management, organization, verbal and written communication skills

  • Proven ability to identify problems of varying complexity and review related information to develop, evaluate and implement solutions

Required/Preferred Education and Experience:

  • Bachelor’s Degree in engineering or other technical discipline.

  • Advanced degree and/or applicable certifications (ASQ CQA or CQE, 6σ Black Belt) desired.

  • 1 - 8+ years’ experience in a Supplier Quality Engineering support role for electronics, metals, plastic injection molded parts, cables and electro-mechanical assemblies.

  • Experience with demonstrated improvements of Supplier Quality by partnering with suppliers to drive supplier improvement activities, and a background in Supplier auditing driving continuous improvements highly desired.

  • Experience using problem solving tools to drive to root cause.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with 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