Quality Management System Manager

Job description

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.
Aurora, IL
Quality Management System Manager
Sonova is seeking a Quality Management System Manager who will be responsible for overseeing and managing the Quality Management System (QMS) at our Aurora, IL facility. This role ensures ISO 13485 certification compliance through internal and external audits, manages key quality processes, and supports site operations by driving continual improvement initiatives and maintaining documentation and regulatory requirements.
Responsibilities:
Quality System Oversight
* Lead ISO 13485 internal and external audits; act as local management representative to maintain site certification.
* Manage CAPA, non-conformance, internal/external audits, management reviews, and training processes.
* Collaborate with Operations and Complaint Management to identify and resolve issues related to product quality and order fulfillment.
* Coordinate document control and ensure proper QA implementation within the eQMS platform.
* Support local continuous improvement efforts such as Kaizen events and quality gemba walks.

Process Management & Reporting
* Host monthly CAPA/NC board meetings and coordinate investigation and resolution of quality trends.
* Initiate and manage non-conformance reports (NCRs), including evaluation, disposition, and containment.
* Maintain site QMS KPIs and report results to regional and global quality teams.
* Participate in daily management meetings to communicate ongoing or emerging quality issues.
* Approve quality documentation and workflows to ensure compliance with internal and regulatory standards.

More About You:

Education & Certifications
* Bachelor’s degree in Engineering, Business, Science, or other technical fields required
* Further certification in Quality Control, Lean, Six Sigma, or similar preferred
* Familiarity with ISO 13485 and U.S. FDA Quality System Regulations preferred

Experience
* Minimum 6 years of experience in a medical device manufacturing environment in a QMS-related role
* Prior experience hosting external audits and managing CAPA/NC coordination

Skills & Competencies
* Self-motivated, proactive, and organized with excellent time management
* Strong analytical, documentation, and communication skills
* Experienced in cross-functional team collaboration and regulatory compliance
* Skilled in quality software systems and MS Office; ERP/CRM experience an asset
* Fluent in English (oral and written)


Travel:
Up to 5%
A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.

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 all in and learn we'd love to hear from you! 
We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact  

 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: $88,000 - $100,000 annually  

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.

Desired profile

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About Sonova AG

Sonova AG