Manager, Sterilization/ Environmental Monitoring

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands – Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron – we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Valencia, CA

Manager, Sterilization & Environmental Monitoring (Hybrid)

This role has responsibility for all quality activities related to the assurance of product sterility and effective environmental monitoring.

• Develops strategies for effective and efficient sterilization of implantable product.
• Ensures any new sterilization equipment and parameters are appropriately developed, tested and deployed.
• Identifies standard processes to be followed at Advanced Bionics for Sterilization and Environmental Monitoring
• Responsible for ensuring the manufacturing environment (e.g. air, surfaces, process water) to maintain levels of control necessary for the manufacture of implantable devices are adequately controlled and monitored.
• Responsible for ensuring adherence to procedures and related guidance and regulations.
• Develops and validates surgical tool reprocessing instructions as needed.
• Accountable for monitoring of product cleanliness (e.g. bioburden, bacterial endotoxins) to demonstrate product sterility and safety.
• Generates reports and presentations demonstrating compliance to sterilization and environmental monitoring requirements, including reporting results out to senior management at Quality Management Reviews.
• Owns any sterilization or environmental monitoring CAPAs and non-conformances.
• Drives continuous improvement of process effectiveness and efficiency.
• Assesses updates to external standards for impact on product and processes related to sterilization and environmental monitoring.
• Supports internal and external audits as subject matter expert.
• Represents Sterilization and Environmental Monitoring activities in internal and external inspections or audits
• Develops, approves and may participate in audit of key suppliers for sterilization and environmental monitoring services.
• Acts as a mentor and coach for the development of direct reports and team members through the use of Performance Objectives, training and development plans, and Performance Management Plans to ensure success of the team.
• Manages consultants as necessary.
• Plans, schedules, and completes projects in support of company, personnel, and direct reports goals and objectives.
• Positively represents the quality function and company in overcoming challenges and problems.
• May manage and develop quality plans associated with Sterilization activities.
• Other duties as assigned.

Travelling Requirement: up to 10%

More about you: Education

• BS in Microbiology or equivalent

• Certifications specific to sterilization

• Experience leading technical teams in sterilization and environmental monitoring

• More than 5 years experience managing in a Class III medical device environment

• English/Proficient (verbal and written)

• Proficient in Microsoft Office suite, including MS Project

• Experience using Agile PLM, SAP and/or Minitab or equivalent statistical software

• Solid GMP documentation understanding

Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD) STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform
• D&I focused: D&I council and employee resource groups
• Plan rules/offerings dependent upon group Company/location.

This role's pay range is between: $93,600/yr - $140,400/yr

We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

=== Company description

Class III Medical Device Manufacturer