At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one? We’re hiring a remote Quality Engineer II for a long-term opportunity. With us, it’s all about finding the job that’s just right.

Quality Engineer II – Sterility Assurance and Environmental Controls
Remote/Work from Home/Virtual
M-F 8am-5pm Eastern Standard Time (EST)
Hourly Pay: $59/hr W2
Enhanced benefits + paid vacation/holidays

JOB OVERVIEW:
The major purpose of the position of to provide technical expertise in the terminal sterilization of medical products. These activities include but are not limited to:

• 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.

This person provides technical expertise by driving and recommending actions, determining project details, monitoring new and emerging developments, implementing visions of future direction, leading, and carrying out programs within a specific area of technology and/or systems and proactively supporting business strategies.

Essential Job Functions – Sterilization Sciences Leadership:

• 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.

Deliverables, Responsible for Developing:

• Sterilization Validation Protocol
  

• Sterility Assurance Assessments
  

• Sterilization Specifications
  

• New Contract Sterilizer Approval Plan

Deliverables, Review and Approval:

• Protocols and Validation Reports
  

• Sterilization Specifications
  

• Supplier Approval Plan
  

• Protocols and Validation Reports

Support maintenance and changes to existing products and or processes:

• 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.
  

• Direct all activities necessary for required revalidations of validated sterilization processes.
  

• 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.

Deliverables, Responsible for Developing:

• Change Control Deliverables and Approval Criteria
  

• Revalidation protocols
  

• Sterilization Specifications

Deliverables, Review and Approval:

• Change Reviews Plans
  

• Revalidation Protocols and Reports
  

• Sterilization Specifications

Systems Compliance:

• 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.

Deliverables, Responsible for Developing

• Audit Plans, Schedules, and Agenda
  

• CAPA’s (Product Development)
  

• Audit Responses
  

• Nonconformance Reports

REQUIREMENTS:

• 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.

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