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Quality Assurance Complaint Handling Specialist

Location: Chelmsford, MA

Resuscitation

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:

Requires 2 year degree or equivalent work experience and 6+ years related experience

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