Quality Assurance Support Specialist

7 days ago

Kitchener, Ontario, Canada Sonova Full time

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

We offer an exciting and challenging work environment, a collaborative culture, opportunities for continuous self-improvement, and a flexible hybrid model work environment. We value diversity and inclusion, and our rich benefits plan includes wellness benefits, paramedical services, and competitive compensation.

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