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Flex

Quality Management System (QMS) Document Control Specialist

Posted 24 Days Ago
Be an Early Applicant
In-Office
Austin, TX, USA
Senior level
In-Office
Austin, TX, USA
Senior level
Responsible for managing and controlling QMS documentation in compliance with FDA and ISO standards, including tracking revisions, supporting audits, and maintaining document lifecycle activities.
The summary above was generated by AI
Job Posting Start Date 05-26-2026 Job Posting End Date 07-30-2026

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

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.

What you'll receive for the great work you provide:

  • Full range of medical, dental, and vision plans
  • Life Insurance
  • Short-term and Long-term Disability
  • Matching 401(k) Contributions
  • Vacation and Paid Sick Time
  • Tuition Reimbursement
Job CategoryQuality

Is Sponsorship Available?

No

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 [email protected] 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).
HQ

Flex Austin, Texas, USA Office

12455 Research Blvd, Austin, Texas, United States, 78727

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