{"id":3144852,"url":"https://alion.io/job/owens-minor-quality-engineer-iii-sterilization","title":"Quality Engineer III - Sterilization","company":{"id":2649053,"name":"Owens & Minor","domain":"owens-minor.com","url":"https://alion.io/company/owens-minor","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":26,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-11-01T06:10:25Z"}},"role":"MedTech","role_family":"MedTech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Alpharetta, United States","Richmond, United States","Atlanta, United States","Tallahassee, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"GMP","optional":false},{"name":"Sterilization Validation","optional":false}],"status":"live","first_seen_at":"2026-10-02T00:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-11-02T00:16:37Z","board_verified":true,"closed_at":null,"days_open":31,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":31},"description":"Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.\nGlobal Reach with a Local Touch\n140+ years serving healthcare\n\nOver 14,000 teammates worldwide\n\nServing healthcare partners in 80 countries\n\nManufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland\n\n40+ distribution centers\n\nPortfolio of 300 propriety and branded product offerings\n\n1,000 branded medical product suppliers\n\n4,000 healthcare partners served\n\nBenefits\nComprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.\n\nEducational Assistance - We offer educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program.\n\nEmployer-Paid Life Insurance and Disability - We offer employer-paid life insurance and disability coverage.\n\nVoluntary Supplemental Programs - We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs.\n\nSupport for your Growing Family - Adoption assistance, fertility benefits (in medical plan) and parental leave are available for teammates planning for a family.\n\nHealth Savings Account (HSA) and 401(k) - We offer these voluntary financial programs to help teammates prepare for their future, as well as other voluntary benefits.\n\nPaid Leave - In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave - including parental leave.\n\nWell-Being - Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs - all at no cost to you.\n\nThe compensation for this position will be between $100,000 - $120,000 annually. Actual compensation will be based on applicable experience and education/training.\nSummary\nThe Quality Engineer III, Sterility Assurance and Environmental Controls provides specialized technical expertise in terminal sterilization, sterility assurance, environmental controls, and related validation activities supporting medical products and manufacturing operations. The role independently executes complex technical work, supports investigations and compliance activities, and partners across functions to ensure sterilization processes and controls meet applicable Quality, regulatory, and business requirements. The position may lead defined technical projects and provides guidance within its area of expertise.\nResponsibilities\nProvides technical expertise in terminal sterilization, sterility assurance, environmental controls, and related Quality-system requirements for medical products.\nDevelops, coordinates, and executes sterilization validation and qualification activities involving ethylene oxide, gamma irradiation, electron-beam irradiation, and other applicable sterilization technologies.\nSupports new-product development and product or material changes by evaluating sterilization requirements, material compatibility, microbial controls, validation requirements, and technical risks.\nDevelops and executes technical protocols, validation plans, reports, specifications, and other documentation required to support sterilization processes and product compliance.\nCoordinates qualification activities for contract sterilization facilities and supports validation of selected sterilization processes.\nEnsures sterilization validation and qualification activities comply with applicable internal requirements, international standards, regulatory expectations, and Quality-system procedures.\nProvides technical support for existing validated sterilization processes, including requalification, revalidation, process changes, product changes, and routine maintenance activities.\nEvaluates product, material, packaging, manufacturing, and process changes to determine potential impacts to sterilization requirements and validated conditions.\nSupports change-control activities by identifying required sterility-assurance deliverables and completing applicable technical assessments and documentation.\nDevelops, maintains, reviews, and updates sterilization-process specifications, procedures, protocols, and technical requirements.\nProvides technical guidance to manufacturing facilities regarding environmental monitoring, contamination control, and sterile-product manufacturing requirements.\nSupports environmental-monitoring and environmental-control programs by reviewing data, identifying trends, evaluating potential risks, and recommending appropriate actions.\nPerforms or supports audits and technical assessments of contract sterilizers, external laboratories, manufacturing facilities, suppliers, and other service providers.\nEvaluates compliance with established sterilization, environmental-control, laboratory, Quality-system, and regulatory requirements.\nSupports investigations involving sterilization failures, process deviations, environmental-monitoring events, product concerns, and other sterility-assurance issues.\nApplies root-cause analysis and risk-management methodologies to investigate technical issues and supports the development and implementation of corrective and preventive actions.\nReviews and supports closure of corrective and preventive actions related to sterilization, environmental controls, and associated Quality systems.\nParticipates in sterility-assurance review meetings and communicates technical findings, risks, trends, and recommended actions to appropriate stakeholders.\nReviews and approves sterilization-related documentation within assigned authority and areas of technical expertise.\nAnalyzes technical data and process performance to identify trends, risks, improvement opportunities, and potential compliance concerns.\nRecommends improvements to sterilization, validation, environmental-control, and Quality-system processes based on technical analysis, industry practices, and regulatory requirements.\nApplies Lean, Six Sigma, risk-management, and continuous-improvement principles where appropriate to improve process effectiveness and reliability.\nPartners with cross-functional teams to resolve technical issues and complete defined product, process, validation, or compliance deliverables.\nLeads defined technical projects, workstreams, or deliverables within the Sterility Assurance and Environmental Controls function.\nProvides technical guidance and knowledge sharing to less experienced employees and cross-functional partners within areas of expertise.\nMonitors developments in sterilization technology, industry standards, regulatory expectations, and technical practices and recommends updates to internal processes as appropriate.\nEscalates significant sterility-assurance, product-quality, environmental-control, or compliance risks to the Director, Quality Engineering and other appropriate stakeholders.\nDemonstrates excellent guest service to internal team members.\nPerforms other related duties as assigned. \nQualifications\nBachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or a related scientific or technical discipline.\n5+ years of progressive experience in terminal sterilization, sterility assurance, microbiology, Quality Engineering, validation, or a related technical discipline within a medical device, pharmaceutical, or similarly regulated environment.\nDemonstrated experience developing and executing sterilization validation and qualification activities for medical products.\nExperience supporting product and process design controls, material changes, manufacturing changes, and sterilization-related technical assessments.\nExperience working with ethylene oxide, gamma irradiation, electron-beam irradiation, or other applicable terminal sterilization technologies.\nExperience supporting or performing audits and assessments of contract sterilizers, laboratories, manufacturing facilities, suppliers, or other external service providers.\nExperience investigating sterilization failures, process deviations, environmental-monitoring events, or related Quality issues.\nExperience supporting corrective and preventive actions, root-cause investigations, change controls, and validation activities.\nExperience working independently on technical assignments and leading defined projects or technical deliverables.\nAdvanced working knowledge of terminal sterilization principles, technologies, validation requirements, and associated Quality-system requirements.\nStrong knowledge of sterility assurance, microbiology, environmental monitoring, contamination control, and sterile-product manufacturing principles.\nWorking knowledge of applicable international sterilization standards, medical-device Quality-system requirements, Good Manufacturing Practices, and regulatory expectations.\nStrong understanding of sterilization validation, qualification, revalidation, process control, and maintenance of validated systems.\nAbility to independently evaluate technical information, identify risks, and develop practical recommendations.\nStrong analytical, investigation, root-cause analysis, and problem-solving skills.\nAbility to work independently in a fast-paced, cross-functional environment.\nPhysical Demands\nSedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker must have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. Ability to lift to 15 lbs. independently not to exceed 50 lbs. without help.\nIf you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.\nOwens & Minor is an Equal Opportunity Employer. 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