Quality Assurance Specialist

1 month 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 ensure compliance with medical device standards and ensure product performance.

Key Responsibilities:
  • Collect and analyze field performance data, complaints, and trends to identify areas for improvement.
  • Conduct analysis and recommend corrective and preventative actions to ensure product reliability and customer satisfaction.
  • Provide specialized quality analysis and reporting as required.
  • Assist in completing biological safety assessments and coordinating risk management processes.
  • Investigate product-related complaints and prepare reports for management.
  • Participate in improvement teams and provide input on quality issues.
Requirements:
  • Degree in Science, Healthcare, Software, or Mechanical Engineering.
  • Minimum 3 years of 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 give presentations and explain complex device quality regulations to non-experts.
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 plan, mentorship program, and career development plans.

Sonova Canada is a certified Great Place to Work, and we are committed to equal treatment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.



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