Principal Sterilization Microbiologist

Minneapolis, MN

Industry: Medical Device Job Number: 147322


Principal Sterilization Microbiologist

Our client is a global manufacturer of class II and III medical device products. They are looking for a Principal Sterilization Microbiologist that will develop, establish and maintain quality engineering methodologies, systems, and practices which will meet customer, client, and regulatory requirements.   They will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. They will provide focused quality engineering support within new product development, operational, or system/services support. Their main priority is serving as the technical expert in the EtO sterilization, Radiation, Steam, Chemical and other Sterilization modalities. They need someone with demonstrated expertise in ethylene oxide sterilization processes; knowledgeable in e-beam, Gamma, terminal liquid chemical sterilization, steam sterilization, reprocessed devices, etc. Also a Subject Matter Expert for FDA, ISO, MDD and and/or quality requirements associated with developing medical devices.

Your Responsibilities Include:
  • Provides leadership role on championing departmental or cross-functional engineering initiatives. Provide sterilization assurance and engineering support to manufacturing operations.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Mentor for technical guidance for identifying and resolving quality issues.
  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Job Type: Contract 

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