Documentation Control Specialist – Medical Device QA

Do you have knowledge of 21 CFR Part 820 and ISO 13485?

SQA is looking for a Documentation Control Specialist to support our medical technology client in the Greater Boston area. The ideal candidate will ensure Quality records are identified, collected, implemented, revised, indexed, filed, stored, and maintained in a manner which ensures integrity and accessibility.

Required skills for this role include:

  • 2-4 years experience and a bachelor’s degree or equivalent is preferred in the medical device industry with demonstrated quality system knowledge including 21 CFR Part 820 (QSR) and ISO 13485
  • Experience administrating, maintaining, and improving Document and Record Control System within Quality Management Systems
  • Reviewing and retrieving calibration certificates and assisting with documenting and investigating failure investigations
  • Maintaining supplier files, active CAPAs, SCARs, and internal audit findings

Job ID: 1809-5627
SQA is an equal opportunity employer and supports workforce diversity.