Description
Job Posting Start Date 05-03-2024 Job Posting End Date 07-08-2024Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.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
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Engineer- Change Control will be based in Austin, TX.
Reporting to the Quality Manager. The Quality Engineer/ Change Control will be responsible for the review of change control packages for compliance to Quality System regulations, GMP and site GDP. These include SOPs, Work instructions, manufacturing documents, electronic batch record templates, deviations and bill of material changes. Assist in managing the logging, reproducing, distributing, storing, retrieving, and updating of electronic and hardcopy versions of documents such as Procedures, Work Instructions, Forms.
Here is a glimpse of what you'll do:
- Ensures documents are properly reviewed, updated, approved and released to remain in compliance with customer requirements, ISO 13485 and FDA CFR 820.
- Ensure that document release packages are accurate, complete and current and that all documents are maintained and controlled.
- Supports QMS Management Reviews, recording minutes, and tracking actions
- Supports Compliance (ISO) and Regulatory (FDA) audits
- Responsible for controlling and issuing control numbers for newly created parts or documents and tracking the history, revision levels and status through the life of the parts/documents.
- May support a team of Quality Management System (QMS) Document Control Technicians and provides training and guidance for that team.
- Responsible for change control activities for Quality System documents.
- May engage in other Quality Systems projects and process improvements enhancements
- Develop new processes to support document and configuration control requirements.
- Serve as the document control focal point for assigned customer projects.
- Develop and implement performance metrics.
The experience we're looking to add to our team:
- 4 years of experience
- Document/ change control experience
- Regulated industry (Medical Device, Pharmaceutical, Biotech)
- Experience with ISO 13485 and FDA CFR 820 Regulations preferred
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
Is Sponsorship Available?
NoFlex 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 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).Apply on company website
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