Document Control Specialist, QA & GMP Documentation
Overview
You will own the electronic Quality Document Management System (QCBD) at a Dallas medical device manufacturer. You will process Engineering Change Orders for Manufacturing Specifications and SOPs, support Corrective and Preventive Actions, Nonconformances, and OOS, and ensure compliance with ISO 13485:2016. You will work directly with the Quality Manager during customer and regulatory audits, and drive special projects. This role offers a launchpad into Quality Management or Regulatory Affairs, with full ownership of document control processes from day one.
What You'll Do9
- 1Maintain the electronic document control system, including all modules, ensuring version control and audit readiness.
- 2Create and route Engineering Change Orders for Manufacturing Specifications and SOPs using QCBD.
- 3Monitor calibration status of Manufacturing and Test Equipment, and trigger recalibration when due.
- 4Maintain Employee Training Requirements and Records, linking training to current SOPs.
- 5Review ISO 13485:2016 and other regulations, and update QMS documents to reflect new requirements.
- 6Revise and update SOPs and Quality Documents after audits or failure investigations.
- 7Assist the Quality Manager during customer and regulatory audits, preparing files and responding to requests.
- 8Support failure investigations by collecting and organizing documentation for Nonconformances, OOS, and Complaints.
- 9Collaborate on regulatory inquiries and certifications, preparing submission packages.
Requirements8
- 1Bachelor's degree in a scientific discipline or equivalent practical experience.
- 22+ years in document control or quality assurance in a GMP environment.
- 3Hands-on experience with QMS and ISO 13485 documentation standards.
- 4Proven ability to write clear and concise SOPs and work instructions.
- 5Strong verbal communication to coordinate with cross-functional teams.
- 6Proficiency with Microsoft Office and electronic document management systems.
- 7Preferred: background in contract manufacturing or production environments.
- 8Ability to work onsite in Dallas, Texas.
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