Kelly Science, Engineering, Technology & Telecom · 19 hours ago
Quality Engineer II Remote
Mechanicsville, VA
Full-time
Remote
Mid, Senior Level
$59/hr - $59/hr
5+ years exp
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Responsibilities
Coordination, development, and execution of validation activities for terminal sterilization methods (ethylene oxide, gamma/E-Beam irradiation) required to support medical product manufacturing.
Provide sterilization sciences expertise and validation subject matter expertise in support of product design and product and/or material changes.
Perform audits of external service contractors/sterilizers and laboratories.
Provide technical expertise to manufacturing facilities in regards to environmental monitoring and sterile product terminal sterilization requirements.
Ensure compliance to quality system and sterilization standards requirements.
Work within cross functional teams in the development of terminal sterilization requirements for new materials/products, specifically focus on material compatibility, microbial controls and validation activities for new product sterilization.
Lead the terminal sterilization validation requirements for new materials/products, specifically focus on material compatibility, microbial controls required and qualification activities for new product/process sterilization validations.
Lead the qualification of the contract sterilization location and validation of the sterilization process selected.
Lead and ensure validation actions are compliant to all international sterilization standards and meet all regulatory compliance requirements for sterile products.
Develop Sterilization Validation Protocol
Develop Sterility Assurance Assessments
Develop Sterilization Specifications
Develop New Contract Sterilizer Approval Plan
Review and approve Protocols and Validation Reports
Review and approve Sterilization Specifications
Review and approve Supplier Approval Plan
Direct all activities necessary for required revalidations of validated sterilization processes.
Actively participate in and/or facilitate the development of deliverables required for product changes.
Where appropriate, implement Design of Experiments and Problem Analysis/Solving concepts within R&E.
Direct all activities necessary for the project team to achieve change control deliverables, specifically deliverables related to sterilization requirements.
Develop, maintain and facilitate the updates to the sterilization process specifications.
Where appropriate, incorporate the concepts of Lean Six Sigma to sterility assurance activities.
Provide sterilization engineering subject matter expertise in the sterilization of medical products.
Develop Change Control Deliverables and Approval Criteria
Develop Revalidation protocols
Develop Sterilization Specifications
Review Change Reviews Plans
Review Revalidation Protocols and Reports
Review Sterilization Specifications
Actively participate in and/or facilitate internal and external audits of the manufacturing facilities and external suppliers for compliance to controls required for the manufacture of sterile medical products.
Actively participate in and/or facilitate internal and external audits of sterilization and laboratory facilities.
Actively participate in and/or facilitate the closure to corrective and preventive actions assigned to Technical Quality in regards to routine sterilization actions/issues.
Implement the Root Cause Analysis concepts to investigate sterilization failures requiring Corrective and Preventative Actions.
Lead, participate in and/or facilitate in quarterly sterility assurance review meetings.
Review, approve and be actively involved in the maintenance and updates to sterilization specifications.
Develop Audit Plans, Schedules, and Agenda
Develop CAPA’s (Product Development)
Develop Audit Responses
Develop Nonconformance Reports
Qualification
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Required
Experienced Quality Engineer with Sterility Assurance and Environmental Controls knowledge.
Minimum of 5 years of collective experience in terminal sterilization activities including: product and process design controls, development and execution of sterilization validation requirements in a medical device environment.
Minimum of 5 years of tactical execution and development of sterility assurance programs for medical products.
Extensive knowledge of various modes for terminal sterilization, Regulatory requirements, material compatibilities, validation requirements and all related sterility assurance activities for medical devices.
Knowledge of design quality and microbiology as it relates to sterilization and validation.
Knowledge and experience with ISO Sterilization Standards, Medical device GMP’s.
Minimum of a Bachelor’s degree in Microbiology, Engineering, Sciences or similar.
Benefits
Enhanced benefits + paid vacation/holidays
Medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability
Retirement savings plan
Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
Transit spending account
Paid sick leave under the applicable state or local plan
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Officer, Vice President, General Manager
Company data provided by crunchbase
