Regional Quality Assurance Specialist

hace 1 semana


Barcelona, Barcelona, España W.L. Gore & Associates A tiempo completo

About the Role: We are seeking a highly skilled Regional Quality Assurance Engineer to join our EMEA Regional Quality Assurance team. In this role, you will be responsible for planning and coordinating all quality-related activities associated with our Economic Operators. This includes the planning and support of Internal and External Audits to maintain our ISO13485 certifications in the region. You will also be responsible for creating Change Orders, Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs) to maintain compliance and improve existing processes as we implement a new electronic Quality Management System.

Responsibilities:

  • Design, develop, and sustain compliant processes and procedures in support of global quality operations.
  • Initiate NCR/CAPA activities as required, including identification of root cause, action planning, and post-implementation effectiveness checks.
  • Have an understanding of regional regulatory needs and requirements, provide input to gap analysis of regulation updates.
  • Support and perform internal and external audits as appropriate.
  • Delivery of appropriate Quality System training to associates and/or third-party employees.
  • Initiate change documentation and prepare quality reports and presentations.
  • Coordinate with and provide QA support to other regional and global functions.

Requirements: To be successful in this role, you will need to have a strong understanding of quality management systems and regulatory requirements. You will also need to have excellent communication and project management skills. If you are a motivated and detail-oriented individual who is passionate about quality, we encourage you to apply for this exciting opportunity.



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