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Quality Assurance Complaint Handling Specialist

ZOLL Medical Corporation

ZOLL Medical Corporation

Quality Assurance
Chelmsford, MA, USA
Posted on Monday, September 25, 2023
Resuscitation, ZOLLMED.com

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!

This individual will support procedural requirements of ZOLL’s complaint handling, customer turn-around and event reporting systems. Perform internal and external audits as part of the corrective and preventive action system. Supports quality improvement, corrective and prevention action program. Provide support to investigations that lead to quality improvements. Works with latitude and independence. Reports to Supervisor.

Essential Functions:

  • Functionality test, evaluate, and trouble shoot devices, subassemblies, and FRU’s (field replacement units)

  • Review product investigation for completeness and to establish root cause as required (system level and / or component level)

  • Communicate with customers and suppliers

  • Document investigations as appropriate

  • Perform root cause analysis of product, including:

    • Leading investigation to establish root cause

    • Coordinating failure analysis of non-conforming / defective material with vendors and outside laboratories

  • Propose and implement corrective action on an as needed basis

  • Perform internal and external audits as part of the corrective and preventive action system

  • Provide guidance & direction to QA Investigators, Level I and / or Level II

Skill Requirements:

  • Knowledge of commonly used concepts, practices and procedures related to electronics technology

  • Basic computer skills in a MS Word environment. Competent with MS Office, including Excel, Access and Word

  • Knowledge of FDA QSR required

  • Knowledge of USA and including international regulatory Medical Device Reporting preferred

  • Must be able to communicate verbally and in writing and work effectively within a multi-disciplined organization

  • Experience with soldering, ESD handling and electro-mechanical assembly methods

  • Experience using mechanical and electrical test equipment

  • Ability to multitask and prioritize

Required/ Preferred Education and Experience:

  • 6+ years related experience

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