Control and Quality Assurance Specialist

Responsibilities:
The Control and Quality Assurance 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.

Key Tasks:

1. Process, release, and control Engineering Change Orders.
2. Create part numbers and Bill of Materials (BOMs) in the ERP system.
3. Process, maintain, and monitor deviations.
4. Process, release, and control all Quality documents (e.g. Standard Operating Procedures (SOPs), Risk Management Documents, Technical Documents, etc.) supporting the lifecycle of product documentation.
5. Manage the calibration of all calibrated equipment and ensure all calibrated equipment is within specification and certification, as required, is maintained.
6. Support the Head of Quality to establish and maintain Quality Systems in a compliant manner.
7. Interact with manufacturing and design engineering, quality regulatory, marketing, customer service, and management.
8. Write, create, update, and submit Quality SOPs, Forms, Templates and other Quality documents for review and approval.
9. Lead Document Control Quality projects and drive the projects to completion within established deadlines.
10. Identify continuous improvements in Document Control processes and drive and implement those improvements.

Requirements:

• A Bachelor's degree is required.
• Experience in a manufacturing environment, preferably in medical devices, is beneficial.
• Three to five years' experience in a Quality Management System, preferably medical devices.