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Quality Assurance Support Specialist
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Kitchener, Ontario, Canada Sonova Full timeSonova is a global leader in innovative hearing solutions, operating 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 a Quality Assurance Support Analyst, you will be responsible for ensuring that...
Quality Assurance Support Specialist
2 months ago
About Sonova
Sonova is a global leader in innovative hearing solutions, operating 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.
Job Summary
We are seeking a Quality Assurance Support Analyst to ensure that all products developed, manufactured, and/or distributed by Unitron/Sonova comply with all appropriate medical device standards and perform their intended function.
Key Responsibilities
- 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.
- Coordinate 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.
Requirements
- Diploma/degree in Science, Healthcare, Software, and/or Mechanical Engineering.
- Minimum 3 years of 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.
About Us
Sonova is an exciting and challenging work environment that values diversity and inclusion. We offer a rich benefits plan, opportunities for continuous self-improvement, and a mentorship program. We are a certified Great Place to Work and believe that a diverse team makes us better.
