Quality Assurance Support Specialist

4 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.

Job Summary:

We are looking for a highly motivated and detail-oriented individual to ensure 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 analyze field performance data and complaints, preparing monthly reports to identify trends and areas for improvement.
  • Track product reliability, servicing, and customer service call logs to inform quality analysis and recommendations.
  • Conduct in-depth analysis of related data to identify opportunities for corrective and preventative actions.
  • Provide specialized quality analysis and reporting as required, collaborating with cross-functional teams to drive quality improvements.
  • Assist in completing biological safety assessments of accessories, assemblies, and finished products.
  • Coordinate risk management processes within project teams, ensuring compliance with regulatory requirements.
  • Participate in project teams responsible for quality activities and deliverables, contributing to the development of quality strategies and plans.
  • Investigate product-related complaints, preparing summaries and reports to management, and making recommendations for improvement.
  • Participate in improvement teams, providing input related to quality issues and contributing to the development of quality improvement initiatives.
Requirements:
  • Degree in Science, Healthcare, Software, 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 regulations.
  • 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, operating through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants. We value diversity and inclusion, offering a collaborative culture, opportunities for continuous self-improvement, and a rich benefits plan.

We are an equal opportunities employer, committed to providing equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

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