QA Document Control & Change Coordinator

Techlink Systems; California; On-site; USD 65,000 - 95,000; Full time

Job summary

TechLink Systems is seeking a Change Order Coordinator to join its quality assurance team in California. You will manage document changes, coordinate reviews, and ensure compliance with 21 CFR 820 and ISO 13485, while maintaining proper documentation practices across the facility.

The role requires a Bachelor's degree, at least two years in QA or document control, and experience with electronic document management systems.

Qualifications

• Bachelor's degree or an equivalent combination of education and experience.
• 2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
• Working Knowledge of 21CFR820, ISO 13485:2016 standard.
• Experience processing changes using an electronic documentation system.
• Experience with technical writing, formatting and trending of data.
• Agile Document Management System experience preferred.

Responsibilities

• Perform the role of Change Order Coordinator for the facility.
• Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
• Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
• Issue document numbers, lab notebooks numbers and part numbers.
• Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
• Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
• Perform Document Control training for new and existing employees.
• Support development of QA-related training materials.
• Assist with training assignment and collection of training metrics in Metro.
• Trend Document Control Metrics for Management Review.
• Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
• Assist with internal and external audits.
• Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes.

Education

Bachelor's degree or equivalent

Tools

EDMS

Job description

TechLink Systems is seeking a Change Order Coordinator to join its quality assurance team in California. You will manage document changes, coordinate reviews, and ensure compliance with 21 CFR 820 and ISO 13485, while maintaining proper documentation practices across the facility.

The role requires a Bachelor's degree, at least two years in QA or document control, and experience with electronic document management systems.