80,000.00

Growing Medical Device Company in the Boston Metro Area is looking for a Document Control Specialist to grow with them.

The Document Control Specialist provides administrative support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, reporting, and closure. They also provide administrative support for other functions such as Post-market Surveillance (PMS).

Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System (CHS) per procedures, GMP’s, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements

Make reportability decision and submit MDR reports

Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause