Document Control Coordinator

Primary Responsibilities

• Maintains, updates 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.
• Functions as an information source for production, and other departments when critical quality documentation issues arise.
• Sets and processes change orders under ISO 13485 and FDA 21 CFR Part 820.
• Maintains 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.
• Updates and maintains product DMR’s.
• Maintains staff training records and working with supervision ensuring that all QCBD training is to current requirements.
• Accurately enters data into EPICOR.
• Provides document support for internal and external audits, as needed.
• May educate and instruct plant personnel in recommended quality control testing and equipment methods and acceptable documentation practices.
• Assists other departments with ad-hoc projects and serves as a backup per business needs.

Qualifications

• Associate degree in applicable technical discipline is strongly preferred or equivalent, or two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training, or equivalent combination of education and experience.
• Basic regulatory knowledge in medical regulations.
• Accuracy of typing skills and extreme attention to detail are required.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.

Shifts

Available: 1st shift

Pay

Salary Range: $26.00 - $30.00/hr based on experience

Benefits

Equal Employer Opportunity