About This Role
This director-level role leads the global Quality System Management and Audit for CRM, overseeing global Microbiology and Sterilization, including direct management of the Sylmar-based Microbiology/Sterilization team and its production manufacturing operation.
Responsibilities
- Organize, host, and execute regulatory audits across the global CRM network
- Develop and drive audit strategies and plans across the CRM global network/sites, in alignment with increasing complexity from global regulatory agencies
- Oversee CRM network microbiology and sterilization
- Directly lead the Sylmar-based micro/sterilization team and production operation
- Drive sterilization acceptance approaches and compliance with appropriate standards across the CRM global manufacturing network
- Evolve, uphold, and ensure compliance of the Quality Management System (QMS)
- Develop and drive strategies for implementing Quality tools, demonstrating acceptability within the quality system
- Manage QMS suppliers and modernize QMS tools
- Drive continuous improvement, keep up with evolving global regulations, and modify QMS (particularly with AI applications to product offerings and QMS execution)
- Develop and manage talent, oversee organizational development, and manage the budget
- Work directly with the FDA and other geographic regulators to enable continued good standing of the CRM business, ensuring unencumbered launch cadence of new product iterations into the market
Requirements
- Bachelor's degree
- Degree in Microbiology highly preferred
- 15 years of experience within engineering, quality, microbiology, or related fields
- In-depth knowledge and experience in medical device regulated businesses, specifically in hosting regulatory audits
- Expertise in microbiology and medical device sterilization techniques
Benefits
- Career development with an international company
- Employees can qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit - an affordable and convenient path to getting a bachelor
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
About the Company
