Quality Assurance Support Specialist
4 weeks ago
Sonova is a global leader in innovative hearing solutions, operating through four businesses – Hearing Instruments, Audiological Care, Consumer Hearing, and Cochlear Implants – and the core brands Phonak, Unitron, AudioNova, Sennheiser, and Advanced Bionics.
As a Quality Assurance Support Analyst, you will be responsible for ensuring that all products developed, manufactured, and/or distributed by Unitron/Sonova comply with medical device standards and perform their intended function.
Key Responsibilities:
- Collect and review field performance data, complaints, and prepare monthly reports.
- Track trends in product reliability, servicing, and customer service call logs.
- Conduct analysis and recommend corrective and preventative actions.
- Provide quality analysis and reporting as required.
- Assist in completing biological safety assessments of accessories, assemblies, and finished products.
- Coordinate risk management processes within project teams.
- Participate in project teams responsible for Quality activities and deliverables.
- Investigate product-related complaints, prepare summaries, and reports to management.
- Participate in improvement teams, providing 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/hearing aid field.
- Familiarity with ISO 13485, MDSAP, and MDR.
- Experience in risk management and documentation is desirable.
- Ability to give presentations to various audiences.
- Ability to understand, interpret, and explain complex device quality regulations.
About Sonova:
- Exciting and challenging work environment.
- Collaborative culture.
- Opportunities for continuous self-improvement.
- Flexible hybrid work environment.
- Diversity and inclusion values.
- Rich benefits plan, including wellness benefits and competitive compensation.
- Mentorship program and career development plans.
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