Validation Quality Engineer

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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.

We’re looking to add a Validation Quality Engineer located in Austin, TX to support our extraordinary teams who build great products and contribute to our growth.

Reporting to the Validation Quality Manager, the Validation Quality Engineer role will be responsible for equipment, facilities, and utilities validation to ensure compliance with internal policies, procedures, and regulatory requirements for medical device manufacturing.

• Provide validation oversight for equipment and facilities qualification activities, ensuring compliance and recommending corrective actions as needed.
• Implement and enforce validation policies and procedures for medical device manufacturing.
• Define qualification requirements and lead assigned validation activities to completion.
• Interface with customers on technical and quality issues, as well as improvement initiatives.
• Author and execute validation plans and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification.
• Make independent decisions related to qualification activities.
• Evaluate alternative methods and procedures to meet business needs.
• Act as a subject matter expert during regulatory, compliance, and customer audits.
• Review technical problems and recommend solutions to improve and streamline quality system processes.
• Implement validation controls across manufacturing areas in accordance with applicable policies and procedures.
• Manage validation and change control activities by authoring, reviewing, and approving deliverables, including validation plans, test protocols/results, risk assessments, traceability matrices, and summary reports.
• Monitor validation activities to ensure adherence to regulations, protocols, and methodologies, and maintain complete documentation.
• Support software validation and quality engineering projects as required by business needs.

• Typically requires a bachelor’s degree in engineering or equivalent experience and training.
• 5+ years of experience working as a validation engineer.
• 4+ years of experience in process and facilities validation within medical device, pharmaceutical, or biotechnology industries; strong understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO 9001, and GAMP standards.
• Working knowledge of validations for processes, facilities, and utilities and statistical analysis is must.
• Experience in generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and change management.
• Project management or software validation experience is a plus.
• Experience in a 24/7 operations environment strongly preferred.

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  and we'll discuss your specific situation and next steps (

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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).

Mid-Senior level

Full-time

Appliances, Electrical, and Electronics Manufacturing