Position Title
Corporate Sterilization & Microbiology Specialist
SBU
Medical
Department
Quality Assurance
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background. Minimum of 5 years of experience in sterilization of medical devices.
Qualification Requirements
Strong communication skills (written and verbal). Regulatory, cGMP, QSR knowledge base. Statistical knowledge (DOE, SPC, Sample comparison, etc.). Computer literate (MiniTab, Word, Excel, etc.). Negotiation and strong problem solving skills. Ability to communicate and operate effectively with multiple teams. Supplier audit skills. Knowledge/experience in EO and gamma radiation sterilization. Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts, reasoning ability.
Preferred Qualifications
N/A
Responsibilities
Oversee processes related to sterilization, biocompatibility, and microbiological methods for products designed and manufactured by Teleflex Medical, as well as purchased products labeled and sold by Teleflex Medical. Evaluate new products and changes to product, including custom and made-to-order kits, for impact of sterilization. Provide expertise to manufacturing plants to solve problems and minimize impact to product flow, while still maintaining an eye for quality and compliance.
Maintain and execute a biocompatibility program/policy for Teleflex
Medical to endure all products and processes comply with the
regulatory standards.
Evaluate impact/efficacy of existing sterilization methods on new
products or new product designs.
Evaluate the impact of new or modified manufacturing material related
changes on biocompatibility.
Evaluate the effectiveness of existing sterilization methods, ethylene
oxide residuals, pyrogenicity, and bioburden on custom or made-to-
order kits.
Provide input to creating strategies to assure compliance to regulatory
standards regarding sterilization for Teleflex Medical products.
Provide input to creating strategies to assure compliance to regulatory
standards regarding biocompatibility for Teleflex Medical products.
Provide expertise during audits of internal and external suppliers
according to a documented audit plan.
Provide oversight and ensure company-wide, consistent and
compliant methods for the following: EO Residuals, biocompatibility,
bioburden monitoring, environmental monitoring, clean-room
practices, and bacterial endotoxin testing. (These are
considered “microbiological methods”.)
Ensure company documentation related to biocompatibility,
sterilization, and microbiological controls are maintained and
updated with most current regulations, standards, and industry
practices.
Perform miscellaneous projects and duties at the direction of Quality
Assurance and Manufacturing Management.
Adhere to and ensure the compliance of Teleflex Medical Code of
Conduct, all company policies, rules, procedures, and housekeeping
standards. Complete special projects as assigned. **Position requires direct contact with Implantable Device**
