Quality Management System Manager

Sonova Group; Mississauga; On-site; USD 88,000 - 100,000; Full time

Job summary

Sonova Group seeks a Quality Management System Manager to oversee ISO 13485 compliance at their Mississauga facility. The role involves managing audits, non-conformance reports, and driving quality improvements. Ideal candidates will have a relevant degree, at least six years’ experience in medical device manufacturing, and possess strong analytical skills.

Benefits

Medical, dental and vision coverage

401k plan with company match

Company paid life/ad&d insurance

Short/Long-Term Disability coverage

Paid parental bonding leave

Employee Assistance Program

Hearing aid discount for employees

Internal social recognition platform

Robust Internal Career Growth opportunities

Flexible Spending/Dependent Care Accounts

Qualifications

• Minimum 6 years in a medical device manufacturing environment.
• Experience in hosting external audits and managing CAPA/NC.
• Fluent in English with strong analytical capabilities.

Responsibilities

• Oversee compliance with ISO 13485 through audits.
• Manage CAPA, non-conformance reports and quality processes.
• Support continuous improvement initiatives.

Skills

Analytical skills

Documentation skills

Communication skills

Time management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Business, Science, or related field

Certification in Quality Control, Lean, Six Sigma or similar (preferred)

Tools

Quality software systems

MS Office

ERP/CRM systems

Job description

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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.

Quality Management System Manager

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.

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 Mississauga 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
• 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 allin 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
• Hearing aid discount for employees and family
• Internal social recognition platform
• D&I focused: D&I council and employee resource groups

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 manag ement. 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.