{"schemaVersion":"jobsearcher.job.v1","id":"14dd1c5e400cc63218699c69","url":"https://jobsearcher.com/jobs/14dd1c5e400cc63218699c69","canonicalUrl":"https://jobsearcher.com/jobs/14dd1c5e400cc63218699c69","title":"Validation Quality Engineer","description":"Job Posting Start Date 12-05-2025 Job Posting End Date\nFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.\nA 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.\nJob Summary\nTo support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Validation Quality Engineer located in Austin, TX.\nReporting 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.\nWhat a typical day looks like:\nProvide validation oversight for equipment and facilities qualification activities, ensuring compliance and recommending corrective actions as needed.\nImplement and enforce validation policies and procedures for medical device manufacturing.\nDefine qualification requirements and lead assigned validation activities to completion.\nInterface with customers on technical and quality issues, as well as improvement initiatives.\nAuthor and execute validation plans and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification.\nMake independent decisions related to qualification activities.\nEvaluate alternative methods and procedures to meet business needs.\nAct as a subject matter expert during regulatory, compliance, and customer audits.\nReview technical problems and recommend solutions to improve and streamline quality system processes.\nImplement validation controls across manufacturing areas in accordance with applicable policies and procedures.\nManage validation and change control activities by authoring, reviewing, and approving deliverables, including validation plans, test protocols/results, risk assessments, traceability matrices, and summary reports.\nMonitor validation activities to ensure adherence to regulations, protocols, and methodologies, and maintain complete documentation.\nSupport software validation and quality engineering projects as required by business needs.\nThe experience we’re looking to add to our team:\nTypically requires a bachelor’s degree in engineering or equivalent experience and training.\n5+ years of experience working as a validation engineer.\n4+ 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.\nWorking knowledge of validations for processes, facilities, and utilities and statistical analysis is must.\nExperience in generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and change management.\nProject management or software validation experience is a plus.\nExperience in a 24/7 operations environment strongly preferred.\nWhat you'll receive for the great work you provide:\nFull range of medical, dental, and vision plans\nLife Insurance\nShort-term and Long-term Disability\nMatching 401(k) Contributions\nVacation and Paid Sick Time\nTuition Reimbursement\nJob Category\nDesign, Process & Technology Engineering\nIs Sponsorship Available?\nNo\nFlex 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).","company":"Flex","rawCompany":"flex","city":"Austin","state":"TX","isRemote":false,"isActive":false,"createdAt":"2026-04-12T17:25:54.534Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Quality Engineer","description":"Job Posting Start Date 12-05-2025 Job Posting End Date\nFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.\nA 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.\nJob Summary\nTo support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Validation Quality Engineer located in Austin, TX.\nReporting 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.\nWhat a typical day looks like:\nProvide validation oversight for equipment and facilities qualification activities, ensuring compliance and recommending corrective actions as needed.\nImplement and enforce validation policies and procedures for medical device manufacturing.\nDefine qualification requirements and lead assigned validation activities to completion.\nInterface with customers on technical and quality issues, as well as improvement initiatives.\nAuthor and execute validation plans and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification.\nMake independent decisions related to qualification activities.\nEvaluate alternative methods and procedures to meet business needs.\nAct as a subject matter expert during regulatory, compliance, and customer audits.\nReview technical problems and recommend solutions to improve and streamline quality system processes.\nImplement validation controls across manufacturing areas in accordance with applicable policies and procedures.\nManage validation and change control activities by authoring, reviewing, and approving deliverables, including validation plans, test protocols/results, risk assessments, traceability matrices, and summary reports.\nMonitor validation activities to ensure adherence to regulations, protocols, and methodologies, and maintain complete documentation.\nSupport software validation and quality engineering projects as required by business needs.\nThe experience we’re looking to add to our team:\nTypically requires a bachelor’s degree in engineering or equivalent experience and training.\n5+ years of experience working as a validation engineer.\n4+ 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.\nWorking knowledge of validations for processes, facilities, and utilities and statistical analysis is must.\nExperience in generating, reviewing, and approving validation deliverables, statistical analysis, risk management, and change management.\nProject management or software validation experience is a plus.\nExperience in a 24/7 operations environment strongly preferred.\nWhat you'll receive for the great work you provide:\nFull range of medical, dental, and vision plans\nLife Insurance\nShort-term and Long-term Disability\nMatching 401(k) Contributions\nVacation and Paid Sick Time\nTuition Reimbursement\nJob Category\nDesign, Process & Technology Engineering\nIs Sponsorship Available?\nNo\nFlex 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).","datePosted":"2026-04-12T17:25:54.534Z","dateModified":"2026-04-12T17:25:54.534Z","hiringOrganization":{"@type":"Organization","name":"Flex","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Austin","addressRegion":"TX","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"14dd1c5e400cc63218699c69"},"url":"https://jobsearcher.com/jobs/14dd1c5e400cc63218699c69"}}