Quality Assurance Support Specialist

1 day 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/or 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 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, 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, and competitive compensation including variable component and employer match on pension contributions.
  • Mentorship program and career development plans.

Sonova Canada is now a certified Great Place to Work May 2024- May 2025.

We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person 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.

We thank all applicants in advance; however, only individuals selected for an interview will be contacted. All applications will be kept confidential.

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