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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.

Aurora (IL), United States

Quality Leader Americas

Director, Quality Americas

Purpose of role: This individual has primary responsibility for leading and directing the quality and regulatory initiatives within the Sonova US organization including Phonak, Unitron, and Hansaton brands.

 

This position is based out of Aurora, Illinois.     

 

Our Offer to You:

  • Improving the quality of life of millions of people suffering from hearing loss
  • A challenging and motivating assignment as part of a dynamic team
  • Modern mindset and processes, accommodating flexible working conditions
  • Opportunities for further responsibilities and support for further training and development
  • Sonova’s outstanding opportunities and career growth

Covid Protocol:

Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all of our newly-hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.

Main Tasks and Responsibities:

  • Provide expertise and coordinate product and process quality activities in order to ensure compliance with Sonova global quality initiatives. These include oversight, training, and direct review of quality documents and records related to implementation and/or compliance with medical regulations
  • Manage and drive QMS compliance remediation as necessary
  • Facilitate driving a quality culture and the corporate strategy for a single QMS
  • Responsible for obtaining and maintaining ISO 13485, ISO 14001, and ISO 9001 certification for Sonova US.
  • Responsible for company compliance to FDA 21 CFR requirements and other applicable regulatory standards
  • Lead the preparation of the site for and represent the company at regulatory inspections from FDA, notified body audits or other regulators as applicable or required. Leads responses to any finding raised during audits
  • Manages the quality engineering team across multiple sites and maintain focus on continuous improvements
  • Build, train, and retain a competent quality organization. Develop and sustain a value driven results-oriented culture
  • Active collaboration and leading by influence across all Sonova US functional areas and other Sonova global business units
  • Leads the CAPA and complaint handling programs to resolve product quality issues
  • Provides leadership to the quality control and quality auditor teams to ensure the safety, quality, and efficacy of all finished products
  • Responsible for raising quality awareness of the Sonova US organization
  • Act as a member of the Senior Management Team

 

 

Education and Skillset:

  • B.S. in an Engineering, Science, or technical area required
  • ASQ Certification (CQM, CQE, CQA, CSSBB, CRE, or other) is a strong plus
  • Regulatory Affairs Certification (RAC or RAPS, or similar) is preferred
  • Minimum 10 years’ experience in operations/quality management in the medical devices industry
  • Strong organizational skills
  • Capable of effectively managing multiple project and objectives concurrently
  • Knowledge of statistics and statistical modeling software is a strong plus
  • Solid understanding of manufacturing in a medical electronics environment
  • Expert in Regulatory and Quality Management
  • Must be a good communicator, both orally and in writing

 

 

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 wholesale.HR@Sonova.com

 

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.