Complaint Handling Associate Engineer

Location: Chelmsford, MA

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!

NOTE: ZOLL now mandates COVID vaccinations subject to legal exemptions

Job Summary:

Reporting to the Manager and/or Supervisor of Quality Assurance, this role will support procedural requirements of ZOLL’s complaint handling, customer turn-around and event reporting systems. Working with latitude and independence, it supports quality improvement and corrective and prevention action programs as well as execute investigations that lead to quality improvements. 

Essential Functions:

  • Support Complaint Handling processes
  • Conduct functionality tests, evaluate, and trouble shoot devices, subassemblies, and field replacement units “FRU’s”
  • Review product investigations for completeness and to determine root cause as required (system level and/or component level)
  • Complete, assist and lead product quality investigations to successful conclusions
  • Provide guidance & direction to QA Investigators
  • Perform internal and external audits as part of the corrective and preventive action system. 
  • Effectively communicate within all facets of ZOLL to ensure smooth workflow and timely completion of tasks
  • Identify corrective and preventive actions.
  • Perform internal and external audits as part of the corrective and preventive action system
  • Identify product/process improvements. Interface with other departments as necessary to implement product/process improvements
  • Perform other duties as assigned

Skills Requirements:

  • Knowledge of commonly used concepts, practices and procedures related to electronics and electro-mechanical technology. Experience using mechanical and electrical test equipment.
  • Strong proficiency with MS Office- 365 platform
  • Knowledge of FDA QSR requirements
  • Knowledge of Medical Device Reporting preferred.
  • Must be able to dynamically communicate verbally and in writing and work effectively within a multi-disciplined organization
  • Ability to multitask and prioritize
  • Minimum 2 years related experience in a regulated environment, preferably medical device.
  • Motivated by working independently and ability to make decisions with confidence
  • Working knowledge of Statistical Analysis and analytical quality problem solving tools

Required/Preferred Education and Experience:

  • Requires 4-year degree (Engineering preferred) or equivalent certifications (CQE)

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