Quality Assurance Support Specialist

4 weeks ago


Kitchener, Ontario, Canada Sonova Full time

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, and Advanced Bionics.

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 medical device standards and perform their intended function.

Key Responsibilities:

  • Collect and review field performance data, complaints, and prepare monthly reports.
  • Track trends in product reliability, servicing, and customer service call logs.
  • Conduct analysis and recommend corrective and preventative actions.
  • Provide quality analysis and reporting as required.
  • Assist in completing biological safety assessments of accessories, assemblies, and finished products.
  • Coordinate risk management processes within project teams.
  • Participate in project teams responsible for Quality activities and deliverables.
  • Investigate product-related complaints, prepare summaries, and reports to management.
  • Participate in improvement teams, providing input on quality issues.

Requirements:

  • Degree in Science, Healthcare, Software, or Mechanical Engineering.
  • Minimum 3 years of experience in a hi-tech product/electronics environment or medical device/hearing aid field.
  • Familiarity with ISO 13485, MDSAP, and MDR.
  • Experience in risk management and documentation is desirable.
  • Ability to give presentations to various audiences.
  • Ability to understand, interpret, and explain complex device quality regulations.

About Sonova:

  • Exciting and challenging work environment.
  • Collaborative culture.
  • Opportunities for continuous self-improvement.
  • Flexible hybrid work environment.
  • Diversity and inclusion values.
  • Rich benefits plan, including wellness benefits and competitive compensation.
  • Mentorship program and career development plans.


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