Design Compliance Expert

2 days ago


Stockholm, Stockholm, Sweden Tobii Dynavox AB Full time
Key Responsibilities

As a Design Quality Assurance Manager, you will have the following key responsibilities:

  • Lead quality assurance processes for hardware development to ensure regulatory compliance and alignment with sustainability goals.
  • Collaborate with cross-functional teams to identify potential quality and safety risks associated with product design and reduce the likelihood of failures in the field.
  • Develop and maintain risk management files for all hardware products, ensuring compliance with international standards and regulations.
  • Work closely with R&D teams to integrate risk mitigation strategies into the design and development phases.

You will also be responsible for:

  • Reviewing design history files and risk management documentation to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
  • Maintaining up-to-date knowledge of international standards and regulations related to hardware products.

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