Manager Sterilization/ Environmental Monitoring

Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life's unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.

Join Sonova. Create sense.

Valencia (CA), United States

Manager, Sterilization/ Environmental Monitoring

154152

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.

Responsibilities:

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

Further Education

Nice to Have

Certifications specific to sterilization

Work Experience

Experience leading technical teams in sterilization and environmental monitoring


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

Languages

English/Proficient (verbal and written)

IT Skills

Proficient in Microsoft Office suite, including MS Project


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

Further Requirements

Solid GMP documentation understanding

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

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

What we offer :

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

How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

Sonova is an equal opportunity employer We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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