Quality Management System Document Control Engineer (Engineering)

At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people's lives.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Management System (QMS) Document Control Engineer will be based in Austin, TX.

Reporting to the Quality Manager. The Quality Management System (QMS) Document Control Engineer will be responsible for managing the logging, reproducing, distributing, storing, retrieving, and updating of electronic and hardcopy versions of documents such as Procedures, Work Instructions, Forms Additionally, Responsible for the maintenance of the Quality Management System (QMS), NCMRs, Deviations, CAPAs, System improvements, Work and all associated documents.

Here is a glimpse of what you'll do:

• Responsible for the maintenance of the Quality Management System (QMS) and all associated documents
• Ensures documents are properly reviewed, updated, approved, and released to remain in control
• Supports QMS Management Reviews, taking minutes and tracking actions
• Supports Compliance (ISO) and Regulatory (FDA) audits
• Ensure that document release packages are accurate, complete, and current and that all documents are maintained and controlled.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
• Responsible for controlling and issuing part numbers for newly created parts or documents and tracking the history, revision levels and status through the life of the parts/documents.
• Develop new processes to support document and configuration control requirements.
• Serve as the document control focal point for assigned customer projects.
• Select and develop personnel to ensure the efficient operation of the production function.
• Responsible for controlling and maintaining the engineering change and documentation tracking process with emphasis on Bills of Material (BOM's), parts masters, specifications, drawings, and documentation to ensure appropriate changes are documented.
• Create, implement, and finalize engineering change orders (ECO's) and makes system changes.
• Develop and implement performance metrics

The experience we're looking to add to our team:

• Bachelor's degree
• 2+ years of experience
• Regulated Industry experience medical device/pharma
• Experience with ISO 13485 / FDA 820

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

• Full range of medical benefits, dental, vision
• Life Insurance
• Matching 401K
• PTO
• Tuition Reimbursement
• Employee discounts at local retailers

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Job Category

Quality

Relocation: Not eligible

Is Sponsorship Available?

No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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 recruitment process. Please advise us of any accommodations you may need by e-mailing: accessibility@flex.com.