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Responsibilities:

• Strong understanding of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat. Act as SME in the sterilization technique
• Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments.
• Participate in the development and improvement of the manufacturing processes for existing and new products.
• May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
• Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
• Support product transfers to other plants/facilities.
• Review/approve nonconforming material and system documentation.
• Review/approve product and process change control documentation and specifications.

Requirements:

• Bachelor's Degree in Microbiology, Biology, Engineering or a closely related life science.
• 6 + years of medical device, pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
• Experience with steam sterilization, preferred
• Knowledge or experience with ETO and/or gamma radiation
• Experience in reprocessing of re-useable medical device instruments and the cleaning validations associated with the devices highly preferred
• Medical device industry experience
• Sterilization certificate and/or training (ETO, Gamma, Steam, Gas Plasma, etc.)
• Excellent written and verbal communication skills