Quality Assurance Engineer

vor 1 Monat

Zürich, Schweiz Envista Vollzeit

Job Description:

The Quality Assurance Engineer is part of the quality department and supports different roles and functions within the organization related to New Product Introduction projects, Life Cycle Management activities, and the Quality Management System.

The Quality Assurance Engineer at Nobel Biocare is responsible for:

  • Ensuring compliant execution of New Product Introduction projects and Life Cycle Management activities, including the review and approval of design control and change control relevant documents, in accordance with internal procedures and applicable regulatory requirements.
  • Acting as a consultant for teams and individuals related to application and interpretation of internal and external procedures, guidance, standards, and regulations to find pragmatic ways to achieve appropriate and compliant documentation of activities.
  • Participating in change control activities (review and approval of change requests).
  • Participating in design review meetings and reviewing respective documentation.
  • Supporting audit activities.
  • Supporting Risk Management activities.
  • Supporting and participating in Corrective and Preventative Action activities.
  • Supporting process owners in the creation and update of procedures.
  • Identifying required updates to processes in the area of responsibility.
  • Supporting internal and external audit preparation.
  • Performing gap analysis on standards and guidance.
  • Providing internal training to associates in the area of responsibility.

Job Requirements:

  • Higher education (bachelor's or master's degree in engineering or science).
  • 2 years of experience in the medical device industry or equivalent regulated industry (preferably in product development, quality management, risk management, or manufacturing of medical devices).
  • Understanding and knowledge of standards and regulations including but not limited to:
    • ISO 13485 - Medical devices -- Quality management systems
    • ISO 14971 - Medical devices -- Application of risk management to medical devices
    • 21 CFR 820 - US FDA Quality System Regulation
    • MDR - Medical Device Regulation 2017/745.

Operating Company: Nobel Biocare

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