{"schemaVersion":"jobsearcher.job.v1","id":"74b56eef08baafe852db31e7","url":"https://jobsearcher.com/jobs/74b56eef08baafe852db31e7","canonicalUrl":"https://jobsearcher.com/jobs/74b56eef08baafe852db31e7","title":"Software Quality Engineer","description":"Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.\n\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.\n\nJob Summary\n\nSummary\n\nThe “Quality Engineer” will be based in Austin, Texas , reporting to\n\nSushanth Mothukuri .\n\nWhat a typical day looks like:\n\nIn this role, you will be responsible for ensuring that software systems developed, implemented, and used within medical device manufacturing operations are appropriately planned, verified, validated, controlled, and maintained in compliance with Flex Quality System requirements and applicable regulatory standards.\n\nThe experience we’re looking to add to our team:\n\nProvide Quality and Validation oversight for software verification and validation activities to ensure compliance with internal procedures, customer requirements, and applicable regulatory standards.\nEnsure software validation policies, procedures, and lifecycle requirements are effectively implemented and maintained from system planning through retirement for non-product software systems supporting medical device manufacturing operations.\nExecutes and manages software validation and control activities. Author, review, approve, and manage software validation deliverables, including:\nValidation Plans\nUser Requirements Specifications (URS)\nFunctional and Design Specifications\nRisk Assessments\nTest Plans, Protocols, and Reports\nTraceability Matrices\nValidation Summary Reports\nChange and Release Documentation\nMonitor validation projects and deliverables to ensure adherence to approved methodologies, validation strategies, documentation requirements, and project timelines.\nAssess software changes, incidents, deviations, and nonconformances to determine validation impact and ensure appropriate actions are implemented.\nPartner with cross-functional teams including IT, Engineering, Manufacturing, Quality, and external customers to support software implementation and validation activities.\nServe as the Quality representative during computerized system deployments, upgrades, maintenance activities, and retirement processes.\nSupport customer, internal, and regulatory audits and inspections by providing software validation documentation, evidence, and compliance expertise.\nReview technical issues and quality system processes and recommend improvements to strengthen compliance, efficiency, and effectiveness.\nDrive and maintain software control practices including change management, access management, data integrity, backup/recovery, and periodic review activities.\nSupport risk management activities and ensure appropriate mitigation measures are implemented and documented.\nContribute to the development and continuous improvement of software validation procedures, templates, and best practices.\nSupport process validation, equipment qualification, and other validation activities as required to meet business objectives.\nundefined\nundefined\nBachelor’s degree in engineering, Computer Science, Life Sciences, Quality, or a related technical discipline.\nMinimum 5 years of experience in Computer System Validation (CSV), Software Validation, or Software Quality within a regulated industry.\nPrevious experience supporting medical device, pharmaceutical, biotechnology, or other FDA-regulated environments.\nStrong knowledge of FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU Annex 11, ISO 13485, GAMP 5and Risk-Based Validation Methodologies\nThorough understanding of Software Development Life Cycle (SDLC) processes and computerized system validation principles.\nExperience reviewing and approving SDLC documentation and validation deliverables.\nKnowledge of Change Management, Incident Management, Configuration Management, Risk Management, Data Integrity Requirements.\nExperience with Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Quality Management Systems (QMS), and other manufacturing software platforms.\nFamiliarity with cloud-based systems and cybersecurity controls is a plus.\nStrong analytical, problem-solving, and decision-making skills.\nExcellent communication and interpersonal skills.\nAbility to manage multiple projects and priorities in a fast-paced environment.\nSelf-motivated with the ability to work independently and collaborate across cross-functional teams.\nStrong organizational and project management skills.\n\nWhat you'll receive for the great work you provide:\n\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\n\nApplication Deadline:\n\nApplications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.\n\nJob Category\nQuality\n\nIs Sponsorship Available?\n\nNo\n\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":"2026-10-22T10:34:36.354Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"}],"industries":[{"code":"513210","title":"Software Publishers","slug":"software-publishers"},{"code":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Software Quality Engineer","description":"Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.\n\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.\n\nJob Summary\n\nSummary\n\nThe “Quality Engineer” will be based in Austin, Texas , reporting to\n\nSushanth Mothukuri .\n\nWhat a typical day looks like:\n\nIn this role, you will be responsible for ensuring that software systems developed, implemented, and used within medical device manufacturing operations are appropriately planned, verified, validated, controlled, and maintained in compliance with Flex Quality System requirements and applicable regulatory standards.\n\nThe experience we’re looking to add to our team:\n\nProvide Quality and Validation oversight for software verification and validation activities to ensure compliance with internal procedures, customer requirements, and applicable regulatory standards.\nEnsure software validation policies, procedures, and lifecycle requirements are effectively implemented and maintained from system planning through retirement for non-product software systems supporting medical device manufacturing operations.\nExecutes and manages software validation and control activities. Author, review, approve, and manage software validation deliverables, including:\nValidation Plans\nUser Requirements Specifications (URS)\nFunctional and Design Specifications\nRisk Assessments\nTest Plans, Protocols, and Reports\nTraceability Matrices\nValidation Summary Reports\nChange and Release Documentation\nMonitor validation projects and deliverables to ensure adherence to approved methodologies, validation strategies, documentation requirements, and project timelines.\nAssess software changes, incidents, deviations, and nonconformances to determine validation impact and ensure appropriate actions are implemented.\nPartner with cross-functional teams including IT, Engineering, Manufacturing, Quality, and external customers to support software implementation and validation activities.\nServe as the Quality representative during computerized system deployments, upgrades, maintenance activities, and retirement processes.\nSupport customer, internal, and regulatory audits and inspections by providing software validation documentation, evidence, and compliance expertise.\nReview technical issues and quality system processes and recommend improvements to strengthen compliance, efficiency, and effectiveness.\nDrive and maintain software control practices including change management, access management, data integrity, backup/recovery, and periodic review activities.\nSupport risk management activities and ensure appropriate mitigation measures are implemented and documented.\nContribute to the development and continuous improvement of software validation procedures, templates, and best practices.\nSupport process validation, equipment qualification, and other validation activities as required to meet business objectives.\nundefined\nundefined\nBachelor’s degree in engineering, Computer Science, Life Sciences, Quality, or a related technical discipline.\nMinimum 5 years of experience in Computer System Validation (CSV), Software Validation, or Software Quality within a regulated industry.\nPrevious experience supporting medical device, pharmaceutical, biotechnology, or other FDA-regulated environments.\nStrong knowledge of FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU Annex 11, ISO 13485, GAMP 5and Risk-Based Validation Methodologies\nThorough understanding of Software Development Life Cycle (SDLC) processes and computerized system validation principles.\nExperience reviewing and approving SDLC documentation and validation deliverables.\nKnowledge of Change Management, Incident Management, Configuration Management, Risk Management, Data Integrity Requirements.\nExperience with Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Quality Management Systems (QMS), and other manufacturing software platforms.\nFamiliarity with cloud-based systems and cybersecurity controls is a plus.\nStrong analytical, problem-solving, and decision-making skills.\nExcellent communication and interpersonal skills.\nAbility to manage multiple projects and priorities in a fast-paced environment.\nSelf-motivated with the ability to work independently and collaborate across cross-functional teams.\nStrong organizational and project management skills.\n\nWhat you'll receive for the great work you provide:\n\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\n\nApplication Deadline:\n\nApplications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.\n\nJob Category\nQuality\n\nIs Sponsorship Available?\n\nNo\n\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":"2026-10-22T10:34:36.354Z","dateModified":"2026-10-22T10:34:36.354Z","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":"74b56eef08baafe852db31e7"},"url":"https://jobsearcher.com/jobs/74b56eef08baafe852db31e7"}}