Quality Assurance Support Specialist

4 weeks ago


Kitchener, Ontario, Canada Sonova Full time

Sonova is a global leader in innovative hearing solutions, offering a wide range of products and services. We are seeking a Quality Assurance Support Specialist to join our team.

Job Summary:

The Quality Assurance Support Specialist 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.

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 Sonova:

Sonova is a global leader in innovative hearing solutions. We offer a collaborative culture, opportunities for continuous self-improvement, and a rich benefits plan.



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