Manager, Sterilization/ Environmental Monitoring
Sonova USA - Santa Clarita, CA
posted 4 months ago
About the position
As the Manager of Sterilization and Environmental Monitoring at Sonova, you will play a crucial role in ensuring the quality and safety of our innovative hearing care solutions. This position is responsible for overseeing all quality activities related to the assurance of product sterility and effective environmental monitoring. You will develop strategies for the effective and efficient sterilization of implantable products, ensuring that any new sterilization equipment and parameters are appropriately developed, tested, and deployed. Your expertise will guide the identification of standard processes to be followed at Advanced Bionics for sterilization and environmental monitoring, ensuring that the manufacturing environment is adequately controlled and monitored to maintain the necessary levels of control for the manufacture of implantable devices. In this role, you will be accountable for monitoring product cleanliness, including bioburden and bacterial endotoxins, to demonstrate product sterility and safety. You will generate reports and presentations that demonstrate compliance with sterilization and environmental monitoring requirements, including reporting results to senior management during Quality Management Reviews. Additionally, you will own any sterilization or environmental monitoring Corrective and Preventive Actions (CAPAs) and non-conformances, driving continuous improvement of process effectiveness and efficiency. You will also assess updates to external standards for their impact on product and processes related to sterilization and environmental monitoring, supporting internal and external audits as a subject matter expert. Your leadership will extend to mentoring and coaching direct reports and team members, ensuring their development through performance objectives and training plans. You will manage consultants as necessary and plan, schedule, and complete projects that align with company goals and objectives. This role requires a proactive approach to positively represent the quality function and the company in overcoming challenges and problems, while also managing and developing quality plans associated with sterilization activities.
Responsibilities
- Develop strategies for effective and efficient sterilization of implantable products.
- Ensure any new sterilization equipment and parameters are appropriately developed, tested, and deployed.
- Identify standard processes to be followed at Advanced Bionics for Sterilization and Environmental Monitoring.
- Ensure the manufacturing environment is adequately controlled and monitored to maintain necessary levels for the manufacture of implantable devices.
- Ensure adherence to procedures and related guidance and regulations.
- Develop and validate surgical tool reprocessing instructions as needed.
- Monitor product cleanliness to demonstrate product sterility and safety.
- Generate reports and presentations demonstrating compliance to sterilization and environmental monitoring requirements.
- Own any sterilization or environmental monitoring CAPAs and non-conformances.
- Drive continuous improvement of process effectiveness and efficiency.
- Assess updates to external standards for impact on product and processes related to sterilization and environmental monitoring.
- Support internal and external audits as subject matter expert.
- Represent Sterilization and Environmental Monitoring activities in internal and external inspections or audits.
- Develop, approve and may participate in audit of key suppliers for sterilization and environmental monitoring services.
- Mentor and coach direct reports and team members through Performance Objectives and training plans.
- Manage consultants as necessary.
- Plan, schedule, and complete projects in support of company, personnel, and direct reports goals and objectives.
Requirements
- Bachelor of Science in Microbiology or equivalent education.
- 5 years of experience in a Class III medical device environment.
- Experience leading technical teams in sterilization and environmental monitoring.
- Proficient in Microsoft Office suite, including MS Project.
- Solid understanding of GMP documentation.
- Experience using Agile PLM, SAP and/or Minitab or equivalent statistical software.
Nice-to-haves
- Certifications specific to sterilization.
- More than 5 years of experience managing in a Class III medical device environment.
Benefits
- Paid parental leave
- Paid holidays
- Disability insurance
- Health insurance
- Dental insurance
- Flexible spending account
- Tuition reimbursement
- Paid time off
- Parental leave
- Employee assistance program
- Vision insurance
- 401(k) matching
- Opportunities for advancement
