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Documentation Specialist

Location: Chelmsford, MA

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!

Responsibilities

Responsible for supporting ZOLL’s Quality System Documentation and the Change Control process (ECOs, ECRs, MCOs, and PDAs) activities related to the ZOLL Agile PLM System.

 

Essential Functions:

  • Create and process Engineering Change Orders (ECOs), Engineering Change Requests (ECRs), Manufacturing Change Orders (MCOs),  and Process Deviation Authorizations (PDAs) based upon input as well as clarifying all input from engineers or other sources
  • Create part and document numbers in Agile to support assigned product assignments as required
  • Follow departmental SOP's to insure proper job related procedures are followed
  • Identify project requirements by interviewing customers, analyzing operations, determining project scope, documenting results and preparing ZOLL documentation
  • Serves as direct liaison to functional process owners to translate and prioritize requirements for assigned Agile projects
  • Ensure that all documents are issued correctly and have no filename errors
  • Responsible for Change Control activity assigned by Product Line
  • Prepare and update ZOLL documentation as required by the Change Control activity including word documents, labeling forms and other types as required
  • Responsible for coordinating with all departments of ZOLL to insure proper records and coding for Agile and Oracle Business systems are properly set
  • Working with Documentation Manager, Agile Administrator and product line Managers to ensure all tasks are completed on time
  • Working with the Agile Administrator to insure that a maintained working knowledge of Agile PLM is up to date
  • Work directly with project managers as Documentation liaison in organizing the control function for projects, and project introduction through the Change Control process. Included in the task is the writing of relevant Change Requests and Change Orders to originate/update of BOMs, Word Documents, and Labeling and Excel Spread sheets as required

Qualifications

• Computer literate; experience with Microsoft Word, Excel and PDF

Working knowledge of Agile PLM and Oracle a plus

 

Required/Preferred Education and Experinece:

  • AS degree or equivalent
  • 2-4 years’ experience in documentation control
  • Working knowledge of part numbering and bill of material (BOM) structuring
  • Working understanding of FDA current good manufacturing practices (CGMP’s) as defined in 21 CFR part 820

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

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