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Quality Engineer III – Sterilization
Owens & Minor. Provide technical expertise in terminal sterilization, sterility assurance, environmental controls, and related Quality-system requirements for medical products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in terminal sterilization, sterility assurance, and validation processes for medical products, with a strong focus on compliance with regulatory standards and Quality-system requirements. Proficient in conducting audits, risk assessments, and providing technical guidance in a cross-functional environment.
Highest-signal resume keywords
Terminal SterilizationSterility AssuranceValidation ActivitiesMicrobiologyQuality Engineering
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Sterilization ValidationEthylene OxideGamma IrradiationElectron-Beam IrradiationRoot-Cause AnalysisRisk ManagementEnvironmental MonitoringContamination ControlGood Manufacturing PracticesQuality-System Requirements
Soft Skills
Analytical SkillsProblem-SolvingCommunicationCollaborationLeadership
Industry Keywords
Medical DevicePharmaceuticalRegulatory ComplianceInternational StandardsContinuous Improvement
Tech Stack
Tools & technologiesElectron
About the role
Key responsibilities & impact- Provide technical expertise in terminal sterilization, sterility assurance, environmental controls, and related Quality-system requirements for medical products
- Develop, coordinate, and execute sterilization validation and qualification activities involving ethylene oxide, gamma irradiation, electron-beam irradiation, and other applicable sterilization technologies
- Support new-product development and product or material changes by evaluating sterilization requirements, material compatibility, microbial controls, validation requirements, and technical risks
- Develop and execute technical protocols, validation plans, reports, specifications, and other documentation supporting sterilization processes and product compliance
- Coordinate qualification activities for contract sterilization facilities and support validation of selected sterilization processes
- Ensure sterilization validation and qualification activities comply with internal requirements, international standards, regulatory expectations, and Quality-system procedures
- Provide technical support for existing validated sterilization processes, including requalification, revalidation, process changes, product changes, and routine maintenance
- Evaluate product, material, packaging, manufacturing, and process changes for impacts to sterilization requirements and validated conditions
- Support change-control activities by identifying sterility-assurance deliverables and completing technical assessments and documentation
- Develop, maintain, review, and update sterilization-process specifications, procedures, protocols, and technical requirements
- Provide technical guidance to manufacturing facilities regarding environmental monitoring, contamination control, and sterile-product manufacturing requirements
- Support environmental-monitoring and environmental-control programs by reviewing data, identifying trends, evaluating risks, and recommending actions
- Perform or support audits and technical assessments of contract sterilizers, external laboratories, manufacturing facilities, suppliers, and service providers
- Evaluate compliance with sterilization, environmental-control, laboratory, Quality-system, and regulatory requirements
- Support investigations involving sterilization failures, process deviations, environmental-monitoring events, product concerns, and sterility-assurance issues
- Apply root-cause analysis and risk-management methodologies and support corrective and preventive actions
- Review and support closure of corrective and preventive actions related to sterilization, environmental controls, and Quality systems
- Participate in sterility-assurance review meetings and communicate technical findings, risks, trends, and recommended actions
- Review and approve sterilization-related documentation within assigned authority
- Analyze technical data and process performance to identify trends, risks, improvement opportunities, and compliance concerns
- Recommend improvements to sterilization, validation, environmental-control, and Quality-system processes
- Apply Lean, Six Sigma, risk-management, and continuous-improvement principles
- Partner with cross-functional teams to resolve technical issues and complete product, process, validation, and compliance deliverables
- Lead defined technical projects, workstreams, or deliverables within Sterility Assurance and Environmental Controls
- Provide technical guidance and knowledge sharing to less experienced employees and cross-functional partners
- Monitor developments in sterilization technology, industry standards, regulatory expectations, and technical practices
- Escalate significant sterility-assurance, product-quality, environmental-control, or compliance risks to the Director, Quality Engineering and other stakeholders
- Demonstrate excellent guest service to internal team members
- Perform other related duties as assigned
Requirements
What you’ll need- Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or a related scientific or technical discipline
- 5+ 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
- Demonstrated experience developing and executing sterilization validation and qualification activities for medical products
- Experience supporting product and process design controls, material changes, manufacturing changes, and sterilization-related technical assessments
- Experience working with ethylene oxide, gamma irradiation, electron-beam irradiation, or other applicable terminal sterilization technologies
- Experience supporting or performing audits and assessments of contract sterilizers, laboratories, manufacturing facilities, suppliers, or other external service providers
- Experience investigating sterilization failures, process deviations, environmental-monitoring events, or related Quality issues
- Experience supporting corrective and preventive actions, root-cause investigations, change controls, and validation activities
- Experience working independently on technical assignments and leading defined projects or technical deliverables
- Advanced working knowledge of terminal sterilization principles, technologies, validation requirements, and associated Quality-system requirements
- Strong knowledge of sterility assurance, microbiology, environmental monitoring, contamination control, and sterile-product manufacturing principles
- Working knowledge of applicable international sterilization standards, medical-device Quality-system requirements, Good Manufacturing Practices, and regulatory expectations
- Strong understanding of sterilization validation, qualification, revalidation, process control, and maintenance of validated systems
- Ability to independently evaluate technical information, identify risks, and develop practical recommendations
- Strong analytical, investigation, root-cause analysis, and problem-solving skills
- Ability to work independently in a fast-paced, cross-functional environment
- Ability to lift to 15 lbs. independently and not exceed 50 lbs. without help
Benefits
Comp & perks- Comprehensive healthcare plan including medical, dental, and vision plans starting on day one for full-time teammates
- Educational assistance for eligible teammates enrolled in an approved, accredited collegiate program
- Employer-paid life insurance and disability coverage
- Voluntary supplemental life, hospitalization, critical illness, and other insurance programs
- Adoption assistance
- Fertility benefits through the medical plan
- Parental leave
- Health Savings Account (HSA)
- 401(k)
- Paid sick days and short-term leave
- Holidays, vacation days, and personal days
- Teammate Assistance Program (TAP)
- Calm Health
- Cancer Resources Services
- Discount programs at no cost