Quality Management System (QMS) Document Control Specialist

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General Purpose:

Responsible for supporting the Quality Management System (QMS) Document Control Supervisor in the

controlled management of QMS documentation, including the logging, distribution, revision, control, storage,

retrieval and maintenance of electronic and hardcopy quality documents (e.g. Policies, Procedures, Work

Instructions, Forms) in compliance with FDA and ISO requirements.

Principle Accountabilities:

 Support the QMS Document Control Supervisor in daily document control activities.

 Maintain controlled QMS documentation in accordance with approved procedures and regulatory

requirements.

 Ensure documents are properly reviewed, approved, released, revised, and archived within the eQMS.

 Support Change Control activities for QMS documents, including tracking revisions and approvals.

 Assign document control numbers and maintain accurate version history, status, and traceability.

 Ensure document release packages are complete, accurate, and current.

 Support records control activities, including retention, retrieval, and audit readiness.

 Support internal, external, ISO, and FDA audits by retrieving documentation and providing objective

evidence.

 Assist in continuous improvement initiatives related to document and configuration control processes.

 Collect and report document control metrics (e.g., review cycle times, on-time release).

 Proactively support department objectives and performance targets.

Minimum Required Qualifications:

 Requires a High School Diploma or equivalent technical training

 5 years of experience in document control within a regulated (FDA/ISO) manufacturing or quality

environment.

 Equivalent combinations of education, experience, and certifications will be considered.

 Strong understanding of FDA 21 CFR Part 820/QMSR, ISO 13485, and Good Documentation and

Manufacturing Practices (GDP/GMP).

 Demonstrated experience managing the document lifecycle (creation, review, approval, release,

revision, archiving).

 Hands-on experience with electronic Quality Management Systems (eQMS) (e.g., Compliance

Quest, Agile)

 Proficiency with Microsoft Office (Word, Excel, PowerPoint) and document formatting using

approved templates.

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).