Summary: The Document Control Specialist role is a critical role within our Quality team and is responsible for assuring that quality documents and records are processed and controlled according to company approved procedures.
- Process (review, track, copy, scan, file, archive and maintain) quality documents and records in electronic and hardcopy format per relevant procedures.
- Process change control orders.
- Review, track, file and maintain employee training records.
- Control engineering lab notebook distribution and retrieval.
- Identify and implement improvements to the document control system.
- Track external documents (e.g. ISO standards etc.) for completion of gaps analysis and update external document log
- Train personnel regarding document format, content, use, control, and the document control system.
- Audit quality records (e.g. device history records, equipment records) for completeness, accuracy, and conformance to appropriate SOP’s.
- Collect and enter data into QA databases as needed.
Experience, Knowledge and Skills Required:
- High School degree required.
- Minimum five years related experience in the medical device industry.
- Intermediate to advanced computer proficiency (MS Word, Excel, and Outlook)
- Excellent communication and time management skills
- Strong attention to detail required.
- Administrative knowledge of Solidworks, Visio, and Adobe Acrobat preferred.
Interested candidates should submit their resume to firstname.lastname@example.org.