Quality Documentation Specialist

Job Description:
The Quality Documentation Specialist is responsible for maintaining control of all quality documentation. This position works independently, with minimal supervision, in accomplishing daily tasks and advising others. This position works closely with all departments to maintain a compliant program. The specialist is responsible for organizing, maintaining, and updating all controlled documents. All functions of the document center must be in compliance with quality system GMP, 21 CFR 820 (FDA), ISO 13485 and other quality standards.

Duties and Responsibilities:

1. Processes, releases, and controls Engineering Change Orders.
2. Responsible for creating part numbers and Bill of Materials (BOMs) in the ERP system.
3. Processes, maintains, and monitors deviations.
4. Processes, releases, and controls all Quality documents (e.g. Standard Operating Procedures (SOPs), Risk Management Documents, Technical Documents, etc.) supporting the lifecycle of product documentation.
5. Manages the calibration of all calibrated equipment and ensures all calibrated equipment is within specification and certification, as required, is maintained.
6. Supports the Head of Quality to establish and maintain Quality Systems in a compliant manner.
7. Interacts with manufacturing and design engineering, quality regulatory, marketing, customer service, and management.
8. Leads Document Control Quality projects and drives the projects to completion within established deadlines.
9. Identifies continuous improvements in Document Control processes and drives and implements those improvements.

Working Conditions:

• <40 lbs. of lifting required for this role.
• <10% of this role is spent traveling.
• Hearing protection, safety glasses, safety shoes, gloves are required for this role.
• Required exposure to biohazard.