Document Control Coordinator
$54,080–$62,400 year
On-site · Elmhurst, Illinois, United States
Job Summary
Maintains and manages QCBD document file system; organizes and oversees QCBD training related to the Quality Management system; executes document approval, release, archival, and obsolescence per the quality system; modifies and documents changes to Quality System Procedures; serves as an information source for production and other departments when critical quality documentation issues arise; submits and processes change orders under ISO 13485 and FDA 21 CFR Part 820; monitors device history records process to meet ISO 13485 and FDA 21 CFR Part 820; performs device history record review; may perform data entry and trend analysis and initiate negative trend corrective actions; works with management in all company areas to resolve document errors/omissions; updates and maintains product DMRs; maintains staff training records and ensures QCBD training is current; accurately enters data into EPICOR; provides document support for internal and external audits as needed; may educate plant personnel in quality control testing and documentation practices; assists other departments with ad-hoc projects and serves as back up per business needs; other duties as assigned.
Required Qualifications
- Associate degree or two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training
- Basic regulatory knowledge in medical regulations
- Accuracy typing skills and extreme attention to detail
- Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations
Desired Qualifications
- Associate degree in applicable technical discipline is strongly preferred or equivalent
- two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training
- Basic regulatory knowledge in medical regulations
- Accuracy of typing skills and extreme attention to detail
- Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.