The compensation for this position will be between $100,000 - $120,000 annually. Actual compensation will be based on applicable experience and education/training.

Summary 

The 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.

Responsibilities

• Provides technical expertise in terminal sterilization, sterility assurance, environmental controls, and related Quality-system requirements for medical products.
• Develops, coordinates, and executes sterilization validation and qualification activities involving ethylene oxide, gamma irradiation, electron-beam irradiation, and other applicable sterilization technologies.
• Supports new-product development and product or material changes by evaluating sterilization requirements, material compatibility, microbial controls, validation requirements, and technical risks.
• Develops and executes technical protocols, validation plans, reports, specifications, and other documentation required to support sterilization processes and product compliance.
• Coordinates qualification activities for contract sterilization facilities and supports validation of selected sterilization processes.
• Ensures sterilization validation and qualification activities comply with applicable internal requirements, international standards, regulatory expectations, and Quality-system procedures.
• Provides technical support for existing validated sterilization processes, including requalification, revalidation, process changes, product changes, and routine maintenance activities.
• Evaluates product, material, packaging, manufacturing, and process changes to determine potential impacts to sterilization requirements and validated conditions.
• Supports change-control activities by identifying required sterility-assurance deliverables and completing applicable technical assessments and documentation.
• Develops, maintains, reviews, and updates sterilization-process specifications, procedures, protocols, and technical requirements.
• Provides technical guidance to manufacturing facilities regarding environmental monitoring, contamination control, and sterile-product manufacturing requirements.
• Supports environmental-monitoring and environmental-control programs by reviewing data, identifying trends, evaluating potential risks, and recommending appropriate actions.
• Performs or supports audits and technical assessments of contract sterilizers, external laboratories, manufacturing facilities, suppliers, and other service providers.
• Evaluates compliance with established sterilization, environmental-control, laboratory, Quality-system, and regulatory requirements.
• Supports investigations involving sterilization failures, process deviations, environmental-monitoring events, product concerns, and other sterility-assurance issues.
• Applies root-cause analysis and risk-management methodologies to investigate technical issues and supports the development and implementation of corrective and preventive actions.
• Reviews and supports closure of corrective and preventive actions related to sterilization, environmental controls, and associated Quality systems.
• Participates in sterility-assurance review meetings and communicates technical findings, risks, trends, and recommended actions to appropriate stakeholders.
• Reviews and approves sterilization-related documentation within assigned authority and areas of technical expertise.
• Analyzes technical data and process performance to identify trends, risks, improvement opportunities, and potential compliance concerns.
• Recommends improvements to sterilization, validation, environmental-control, and Quality-system processes based on technical analysis, industry practices, and regulatory requirements.
• Applies Lean, Six Sigma, risk-management, and continuous-improvement principles where appropriate to improve process effectiveness and reliability.
• Partners with cross-functional teams to resolve technical issues and complete defined product, process, validation, or compliance deliverables.
• Leads defined technical projects, workstreams, or deliverables within the Sterility Assurance and Environmental Controls function.
• Provides technical guidance and knowledge sharing to less experienced employees and cross-functional partners within areas of expertise.
• Monitors developments in sterilization technology, industry standards, regulatory expectations, and technical practices and recommends updates to internal processes as appropriate.
• Escalates significant sterility-assurance, product-quality, environmental-control, or compliance risks to the Director, Quality Engineering and other appropriate stakeholders.
• Demonstrates excellent guest service to internal team members.
• Performs other related duties as assigned.

Qualifications

• Bachelors 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.

 Physical Demands

• Sedentary 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.

If 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.