Validation Quality Engineer

Job Posting Start Date 02-25-2026 Job Posting End Date<p style="text-align:inherit"></p><p style="text-align:inherit"></p>Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.<p style="text-align:inherit"></p><p style="text-align:inherit"></p>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.<p style="text-align:inherit"></p><p style="text-align:inherit"></p><h2></h2><h2>Job Summary</h2><p><span>To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a <b>Validation Quality Engineer</b> located in <b>Austin, TX.</b></span></p><p></p><p><span>Reporting to the Validation Quality Manager, the<b> Validation Quality Engineer</b> role </span>will be responsible for equipment, facilities, and utilities validation to ensure compliance with internal policies, procedures, and regulatory requirements for medical device manufacturing.</p><p></p><p><b>What a typical day looks like:</b></p><p></p><ul><li>Provide validation oversight for equipment and facilities qualification activities, ensuring compliance and recommending corrective actions as needed.</li><li>Implement and enforce validation policies and procedures for medical device manufacturing.</li><li>Define qualification requirements and lead assigned validation activities to completion.</li><li>Interface with customers on technical and quality issues, as well as improvement initiatives.</li><li>Author and execute validation plans and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification.</li><li>Make independent decisions related to qualification activities.</li><li>Evaluate alternative methods and procedures to meet business needs.</li><li>Act as a subject matter expert during regulatory, compliance, and customer audits.</li><li>Review technical problems and recommend solutions to improve and streamline quality system processes.</li><li>Implement validation controls across manufacturing areas in accordance with applicable policies and procedures.</li><li>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.</li><li>Monitor validation activities to ensure adherence to regulations, protocols, and methodologies, and maintain complete documentation.</li><li>Support software validation and quality engineering projects as required by business needs.</li></ul><p></p><p><b>The experience we’re looking to add to our team:</b></p><ul><li>Typically requires a bachelor’s degree in engineering or equivalent experience and training.</li><li>5&#43; years of experience working as a validation engineer.</li><li>4&#43; 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.</li><li>Working knowledge of validations for processes, facilities, and utilities and statistical analysis is must.</li><li>Experience in generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and change management.</li><li>Project management or software validation experience is a plus.</li><li>Experience in a 24/7 operations environment strongly preferred.</li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:left"><b>What you&#39;ll receive for the great work you provide:</b></p><ul><li>Full range of medical, dental, and vision plans</li><li>Life Insurance</li><li>Short-term and Long-term Disability</li><li>Matching 401(k) Contributions</li><li>Vacation and Paid Sick Time</li><li>Tuition Reimbursement</li></ul><h2></h2><h2>Job Category</h2>Design, Process &amp; Technology Engineering<p style="text-align:inherit"></p><p style="text-align:inherit"></p><h2></h2><p style="text-align:inherit"></p><p style="text-align:left">Is Sponsorship Available?</p>No<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>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 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).