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Supplier Quality Engineer

Location: Pawtucket, RI

Resuscitation

Overview

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:

Responsible for Bio-Detek’s Supplier Quality program. Assist the Materials, Quality Assurance, Engineering and Manufacturing departments with the dayto-day issues relating to supplier certification, validation and quality.  

Responsibilities

  • Maintain Supplier Quality program 
  • Manages suppliers through the review of supplier performance data, communication of supplier performance and driving improvements in supplier’s delivered quality 
  • Manage validation and approval of supplier proposed changes 
  • Daily quality support for issues related to supplier materials arising at incoming inspection and on the manufacturing floor  
  • Conduct periodic surveillance audits at existing suppliers
  • Perform qualification audits on potential new suppliers 
  • Supports new product introduction, cost reduction and part sourcing activities through the completion of outsourced validations of Bio-Detek designed parts and/or assemblies 
  • Works independently or as part of a team to conduct internal investigations for identified nonconformances, including root cause analysis and implementation of corrective or preventative actions
  • Supports the R&D and Materials departments with the identification and selection of suppliers in the new product development process 
  • Maintain supplier files, including qualification documentation and audit reports as required 
  • Other duties as assigned

Qualifications

  • Minimum 5 years experience in a quality engineering support role, preferably for electronics, cables, wires, and hydrogel 
  • Experience with demonstrated improvement of supplier quality and a strong background in supplier auditing 
  • Strong background in ISO 13485, ISO 9001, and FDA 21 CFR 820 
  • ASQ CQA Certification required, CQE Certification a plus 
  • Excellent verbal & written communication skills
  • Minimum of a Bachelor’s degree in Engineering or other technical or science discipline

 

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