Quality Assurance Expert
1 week ago
Job Summary:
Sonova AG, a global leader in innovative hearing solutions, is seeking a Quality Assurance Support Specialist to ensure that all products developed, manufactured, and 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 Electronics, Software, and/or Mechanical Engineering
- Minimum 3 years' 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, etc.) and competitive compensation including variable component and employer match on pension contributions
- Mentorship program and career development plans
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