Job Posting Start Date 09-12-2024 Job Posting End Date 11-25-2024
Flex 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.
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Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Engineer will be based in Austin, TX .
Reporting to the Quality Manager . The Quality Engineer will create, evaluate, manage, route, and organize training for deviations for processes used in development and production of medical products, ensuring the deviations are complaint to regulatory expectations, have customer approval, and are executed within time requirements.
Here is a glimpse of what you'll do:
- Lead all phases of deviation development.
- Provide quality input deviations to outline changes to existing processes.
- Apply Quality Systems oversite for actions and compliance requirements to deviations.
- Route deviations within the Flex Flow System for Flex and Customer approval
- Monitor open deviations to ensure associated actions to resolve the deviation are progressing.
- Participate in investigations for deviations, non-conformances, and CARs.
- Write and revise standard operating procedures describing the deviation process.
- Assist in providing training and guidance to applicable operators and technicians.
- Establish priorities and schedule activities to ensure timelines and milestones are met.
- Maintains databases to track deviation activities.
- Interprets customer requirements.
- Keeps up to date on industry standards and regulations.
- Participate in other Quality Engineering projects as needed for process improvements, investigations and other duties as needed.
- Available for off hours manufacturing support required.
- Typically requires a bachelor's degree in related field or equivalent experience.
- Requires 4 years of quality systems experience.
- Deviation experience
- Medical device industry experience (ISO13485)
- Previous audit experience (prefer)
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- PTO
- Tuition Reimbursement
- Employee discounts at local retailers
Quality
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 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).