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Quality Assurance Support Specialist

2 months ago

Kitchener, Ontario, Canada Sonova Full time
Job Summary

Sonova is a global leader in innovative hearing solutions, and we're seeking a Quality Assurance Support Analyst to ensure our products meet medical device standards and perform as intended.

Key Responsibilities
  • Collect and analyze field performance data, complaints, and customer service call logs to identify trends and areas for improvement.
  • Conduct in-depth analysis of data and recommend corrective and preventative actions to ensure product reliability and safety.
  • Provide specialized quality analysis and reporting as required, including biological safety assessments and risk management coordination.
  • Investigate product-related complaints, prepare summaries, and make recommendations to management.
  • Participate in project teams responsible for quality activities and deliverables, and contribute to improvement teams focused on quality issues.
Requirements
  • Degree in Science, Healthcare, Software, or Mechanical Engineering, or equivalent experience.
  • 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 regulations.
  • Experience in risk management and documentation is desirable.
  • Ability to communicate complex device quality regulations to non-experts and present to various audiences.
About Sonova

Sonova is a global leader in innovative hearing solutions, with a collaborative culture and opportunities for continuous self-improvement. We value diversity and inclusion, and offer a rich benefits package, mentorship program, and career development plans.

Sonova Canada is a certified Great Place to Work, and we're committed to creating a sense of belonging for all employees.