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Quality Systems Specialist

3 months ago

Manchester, New Hampshire, United States DEKA Research & Development Full time

DEKA R&D has an immediate opening for a Quality Systems Specialist to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality System Management Team Leader. This is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:

  • Review and Approve Quality System Records
  • Process changes for QMS Procedures (SOPs)
    • Make red-line changes
    • Process ECOs to approval signatories
    • Make new master documents, archive and distribute via electronic system
    • Track training for QMS documents within the ECO process
    • Track open impacts to completion
  • Support updating procedures and processes to support the QMS
  • Support the site Corrective and Preventive Action program
  • Filing records manually and electronically
  • Support QMS collection and trending of quality data
  • Manage QMS databases for action items and implementation
  • Support external and internal audits
  • Support as backup to Training Coordinator and CAPA Coordinator
  • Provide training as required to DEKA personnel
  • Promote QMS awareness to non-QA departments throughout DEKA

Skills needed to be successful:

  • Preferred experience 2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 3+ years' QMS or document centric environment without degree
  • Experience with documentation in a regulated field such as medical
  • Computer skills with Microsoft Office Suite
  • Strong written/verbal communication skills
  • Ability to:
    • Learn custom software programs
    • Multitask and carry tasks through to completion
    • Manage multiple sources of data and develop reports
    • Manage multiple sources of data and develop reports

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.