Quality Assurance Support Specialist

3 days ago

Kitchener, Ontario, Canada Sonova Full time
Job Title: Quality Assurance Support Analyst

Sonova, a global leader in innovative hearing solutions, is seeking a Quality Assurance Support Analyst to join our team. As a Quality Assurance Support Analyst, you will play a critical role in ensuring that all products developed, manufactured, and distributed by Unitron/Sonova comply with all appropriate medical device standards and perform their intended function.

Key Responsibilities:
  • Collect and analyze field performance data and complaints to identify trends and areas for improvement.
  • Track and analyze data related to product reliability, servicing, and customer service call logs.
  • Conduct in-depth analysis of related data and recommend corrective and preventative actions.
  • Provide specialized 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, and make recommendations where possible.
  • Participate in improvement teams, providing input related to quality issues.
Requirements:
  • 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, and MDR.
  • Experience in risk management and documentation is 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, with a collaborative culture and exciting work environment. We offer opportunities for continuous self-improvement, flexible hybrid work models, and a rich benefits plan, including wellness benefits and competitive compensation. Sonova Canada is a certified Great Place to Work.

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