Senior Sterility Assurance Microbiologist

hace 2 semanas

Tijuana, Baja California, México Merit Medical Systems Inc. A tiempo completo

Job Summary

Merit Medical Systems Inc. is seeking a highly skilled Senior Sterility Assurance Microbiologist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the sterilization of our medical devices meets the highest standards.

Key Responsibilities

  1. Supports New Product Development, Acquisition and Operations Engineering teams creating and implementing plans for sterility assurance activities to support new/modified products/processes for the assigned region/site.
  2. Communicates and interfaces with contract sterilizers, laboratories, and internal customers (R&D, Operations, Regulatory Affairs and Sterility Assurance) as required to effectively manage day to day processing requirements.
  3. Performs and documents product qualifications into existing EO sterilization cycles using the appropriate standards development/modification of sterilization processes for new or existing products.
  4. Performs and documents product adoptions into existing EO cycles, including selection and justification of master product.
  5. Develop, review and approve sterilization process qualifications and routine dose audits.
  6. Develop, qualify and implement microbiological test methods to support sterility assurance of products.
  7. Review sterilization and laboratory documentation to ensure compliance with procedures.
  8. Support cleanroom and installation and qualification activities including protocol development, review and/or approval.
  9. Provide environmental monitoring inputs, conduct and/or manage testing (contract testing laboratories), analyze data and write test reports as applicable.
  10. Review sterilization and environmental documentation to ensure compliance with procedures and applicable regulations.
  11. Lead or participate in sterility assurance technical audits for Merit manufacturing sites and for contracted services.
  12. Keep abreast of current technologies and regulatory standards.
  13. Align to and drive for global standardization and harmonization specific to the policies, procedures and working instructions that produce product sterility assurance and regulatory compliance.
  14. Drives ongoing sterilization programs and projects for Merit harmonizing, where possible, the quality systems and processes used throughout Merit. All changes to the Merit sterilization program should align within Merit corporate quality goals, while maximizing Merit productivity and maintaining a high level of regulatory compliance.
  15. Actively coordinate, train and develop a staff of sterility assurance professionals dedicated to ensuring the product release, change control, validation/adoptions, contract management, experimentation and all associated activities deliver customer satisfaction through product quality, process efficiency, sterility assurance and national and international regulatory compliance.
  16. Keep self, staff and company current on ANSI, AAMI, ISO, USP, EPA and all other national and international standards that ensure product sterility assurance, employee safety and regulatory compliance.
  17. Performs a variety of other related tasks, as required.

Requirements

  • Degree in Quality Engineering/Engineering/Science, or equivalent qualification essential (NFQ Level 7, or higher).
  • A minimum of 7 years relevant experience within a medical device/pharmaceutical manufacturing facility, with at least 5 years having performed activities associated with sterilization and control of microbial contamination of products and processes, coupled with a proven track in leading functional area through regulatory inspections.
  • In depth knowledge and experience of sterilization technologies, and their associated guidance standards (11135, 11137, 17665, etc.).
  • Applied knowledge in ethylene oxide, irradiation &/or steam sterilization modes, including validation at a minimum; knowledge in other sterilization techniques such as aseptic filling most desirable.
  • Applied knowledge of microbiological labs, controlled environments, and sterile barriers.
  • Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC & MDR EU 2017/745), Invitro Diagnostic Medical Device Directive (93/79/EC & MDR EU 2017/746), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), and JPAL/JGMP as they pertain to Sterility Assurance.
  • PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.

Preferred Qualifications

  • Degree in Microbiology.
  • Master's degree.

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