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Change Analyst - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 12/5/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:
    12/5/2018

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Job Functions

  • Analyze structure configuration for Design History Files (DHFs) and Development Lifecycle Device Master Records (DMRs) for completeness within the database (Agile PLM). The content is driven by standard operating procedures.
  • Ensure data accuracy and completeness for Development Lifecycle Engineering and Manufacturing documentation.
  • Responsible for the approvals and configuration release for DHFs and Development Lifecycle DMRs as multi-level complex BOM structures through the change control process, Developing Change Orders (DCOs) within the database (Agile PLM).
  • Accountable for ensuring documentation follow GDP and SOP’s as defined by Atrium’s policies, procedures, and Quality Management System (QMS) to ensure that FDA and ISO standards are consistently met.
  • Assists in training employees for creating, maintaining, and obsoleting complex multi-level BOM configurations and engineering documentation within the database (Agile PLM) for DHFs and Development Lifecycle DMRs.
  • Maintains the database (Agile PLM) and a complete historical record of all DHF, and Development Lifecycle DMR documentation through revision control.
  • Perform related duties as required.

Required Knowledge, Skills and Abilities:

  • High School Diploma or equivalent, with direct experience in engineering documentation and BOM structures.
  • Minimum three years experience in Document Control in a QMS regulated industry. 
  • Demonstrated ability to communicate effectively, with clear and concise oral and written communication.
  • Customer driven work ethic with a sense of urgency/priority in responding to customer needs. 
  • Strong working knowledge of MS Office applications (Excel, Word).
  • Strong knowledge of electronic documentation management system (Agile PLM preferred).

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

 

#LI-DV1

#CBD#

We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

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