Associate Quality Technician
CurrentReviews and ensures that manufactured product meets its device master record requirements and is ready for product release and creates CofCs for released kits. Creates a nonconforming material report (NCMR) and Unplanned Deviation (UPDEV), if deficiencies are found. QA verification of MRB and QAHOLD on materials in ERP system. Assist in verifying contained MRB and QAHOLD materials as needed. Responsible for handling tasks associated with Document Control, including processing, archival, filing, scanning, indexing, and formatting new and existing documents within guidance of the document control QMS procedures and the MasterControl documentation software. Actively manages the document record retention process through the contracted documentation archival supplier. Assures records archived are well documented and logged to support potential future retrieval records as needed. Provide guidance to product release staff and stakeholders in the review and release of manufacturing batch records Working with Document Control in archiving and retrieval of retained paper records. Support quality system audits by providing requested manufacturing batch records. Other duties may be assigned.
