Quality Management System (QMS) Document Control Specialist
Job Location:
Austin, TX - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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 youll 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 Category
QualityIs Sponsorship Available
NoFlex 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. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well 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).Required Experience:
IC
About Company
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