Quality Assurance Support Analyst

4 months ago


Kitchener, Canada Sonova Full time

Sonova is a global leader in innovative hearing solutions: from personal audio devices and wireless communication systems to audiological care services, hearing aids and cochlear implants. We operate through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova, Sennheiser (under license) and Advanced Bionics as well as recognized regional brands. At Sonova we create sense by bringing sound to life.

Overview: As a Quality Assurance Support Analyst you will be responsible for ensuring that all products developed, manufactured and/or distributed by Unitron/Sonova comply with all appropriate medical device standards and perform their intended function.

What you’ll do:

Collect and/or download field performance data and complaints, review, and prepare monthly reports. Track trends in data related to product reliability, servicing and customer service call logs. Conduct analysis of related data and recommend appropriate corrective and/or preventative actions. Provide specialized quality analysis and reporting as required. Assist in completing biological safety of medical device assessment of accessories, assemblies and finished products. Co-ordination of risk management process within the project team. Participate on project teams responsible for Quality activities and deliverables. Investigate product related complaints. Prepare summaries and reports to management, make recommendations where possible. Participate on improvement teams, providing input related to quality issues. Perform other duties as requested by Manager.

What you bring to the team:

Diploma/degree in Science/ Healthcare, Software and/or Mechanical Engineering Minimum 3 years experience in a hi-tech product/electronics environment or medical device or hearing aid field Familiarity with ISO 13485, MDSAP, MDR Experience in risk management and documentation will be desirable Ability to give presentations to a wide spectrum of audiences Ability to understand, interpret and explain complex device quality regulations to non-experts

What makes us a great place to work for:

Exciting and challenging work environment Collaborative culture Opportunities for continuous self-improvement Opportunities for flexible hybrid model work environment A company that values diversity and inclusion Rich benefits plan including wellness benefit, paramedical (massage therapist, naturopath, and competitive compensation including variable component and employer match on pension contributions Mentorship program and career development plans

Sonova Canada is now a certified Great Place to Work May 2024- May 2025.

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

We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential.



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