Quality Assurance Expert

2 months ago

Kitchener, Ontario, Canada Sonova AG Full time

Job Summary:

Sonova AG, a global leader in innovative hearing solutions, is seeking a Quality Assurance Support Specialist to ensure 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/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 Electronics, Software, and/or Mechanical Engineering
  • Minimum 3 years' 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

What We Offer:

  • Exciting and challenging work environment
  • Collaborative culture
  • Opportunities for continuous self-improvement
  • Opportunities for flexible hybrid model work environment
  • A company that values diversity and inclusion
  • Rich benefits plan including wellness benefit, paramedical (massage therapist, naturopath, etc.) and competitive compensation including variable component and employer match on pension contributions
  • Mentorship program and career development plans

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