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 Nobel Biocare is responsible to:

• ensure a compliant execution of new Product Intoduction 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
• act as a consultant for teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities
• participate in change control activities (review and approval of change requests)
• participate in design review meetings and review of respective documentation
• support audit activities
• support Risk Management activities
• support and participate in Corrective and Preventative Action activities
• support process owners in the creation and update of procedures
• identify required updates to processes in the area of responsibility
• support internal and external audit preparation
• perform gap analysis on standards and guidances
• providing internal training to associates on area of responsibility

LI-MK1

JOB REQUIREMENTS:

• Higher education (bachelor or master 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 on standards and regulation 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.

Please refer the Job description for details