Design and conduct research and/or process improvement projects pertaining to microbiological control and sterilization of Zimmer products. Conduct quality assurance activities required to support, evaluate, document and audit the sterilization of Zimmer orthopedic products.
- Prepare test protocols and final reports for research and validation projects.
- Design and conduct validation and process improvement projects pertaining to microbiological control and sterilization.
- Conduct QSR/ISO audits of contract sterilization vendors and contract laboratories.
- Perform quality assurance activities (sterilization shipment review, dose mapping studies, review of gas plasma sterilization records, etc.) as required to support the Zimmer sterility assurance program. Provide technical guidance to Manufacturing, Development Engineering, and Research Departments on issues related to microbiological control and product sterilization.
- Prepare and conduct training sessions for microbiology lab technicians and manufacturing cleanroom personnel.
Expected Areas of Competence;
- Direct experience supporting a manufacturing environment
- Proficient in Environmental monitoring requirements of a Class 6 and 7 cleanroom
- Experience with Gamma and EO sterilization validations and routine monitoring
- Experience in supervision of other microbiologist / micro technician
- Must possess knowledge of current OSR regulations and AAMI/ISO standards pertaining to industrial sterilization and microbiological control.
- Demonstrated strong writing and communication skills.
- Strong attention to details, and ability to multitask.
- Strong computer skills.
Education/ Experience Requirements
- Bachelor's Degree in microbiology or biology with a concentration of course work in microbiology
- Must have at least two years of industrial microbiology experience working with medical devices or pharmaceuticals in the laboratory setting; or equivalent combination of education and experience
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.