Quality Assurance Coordinator

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 Analyst to ensure compliance with medical device standards and ensure product performance.

Key Responsibilities:

  • Collect and analyze field performance data and complaints to identify trends and areas for improvement.
  • Track product reliability, servicing, and customer service call logs to inform quality decisions.
  • Conduct in-depth analysis of data to recommend corrective and preventative actions.
  • Provide specialized quality analysis and reporting as required.
  • Assist in completing biological safety assessments of medical devices.
  • Coordinate risk management processes within project teams.
  • Participate in project teams responsible for quality activities and deliverables.
  • Investigate product-related complaints and prepare summaries and reports for management.
  • Participate in improvement teams to provide input on 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 field.
  • Familiarity with ISO 13485, MDSAP, and MDR regulations.
  • Experience in risk management and documentation is desirable.
  • Ability to present complex information to diverse audiences.
  • Understanding and interpretation of complex device quality regulations.

What We Offer:

  • Exciting and challenging work environment.
  • Collaborative culture.
  • Opportunities for continuous self-improvement.
  • Flexible hybrid work environment.
  • A company that values diversity and inclusion.
  • Rich benefits package, including wellness benefits and competitive compensation.
  • Mentorship program and career development plans.

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