Oakland-Fremont-Pleasanton Metro Area, CA
- This position is responsible for managing the document and change control process, document support for development and design history files, and management of supplier files and training records.
- Manage Document Control process. Assign document numbers, part numbers, lot numbers to ensure compliance with document numbering structure.
- Coordinate QA Document Change Orders (DCOs). Provide guidance to document initiators in document formatting according to the templates and General Operating Procedures (GOPs). Format documents according to templates.
- Set up training records for new employees and manage training matrix. Collaborate with supervisors to ensure training records are updated. Coordinate training.
- Oversee supplier records, supplier evaluations, and supplier reviews. Maintain Approved Supplier List.
- Oversee CAPA, Nonconformance and Deviation records. Maintain records and logs.
- Manage Design History File with Product Development. Manage DHF index. Support Development in creation and maintenance of BOMs, part specifications, and manufacturing drawings and instructions.
- Perform review and approval of production records, including incoming material and in-house batch records.
- Ensure quality records and reports are reviewed, organized and filed.
- Gather and publish metrics for management review.
- Support internal and external audits.
- Bachelor s degree in Life Science, Engineering, Computer Sciences or another related discipline or comparable experience.
- Minimum of 2-5 years related experience in document control, quality records management, records review and approval.
- Strong interpersonal skills, ability to work independently and in teams.
- Experience with US FDA regulations for medical devices, plus international preferred.
- Experience with IVD products, following applicable guidelines, is preferred.