Regional Quality Assurance Specialist

hace 2 días

Madrid, Madrid, España W. L. Gore & Associates, Inc A tiempo completo

**Job Summary**

W. L. Gore & Associates, Inc is seeking a highly skilled Regional Quality Assurance Engineer to join our EMEA Regional Quality Assurance team. As a key member of our team, you will be responsible for planning and coordinating all quality-related activities associated with our Economic Operators and the planning and support of Internal and External Audits to maintain our ISO13485 certifications in the region.

**Key Responsibilities:**

  • Design, develop, improve, and sustain compliant processes and procedures in support of global quality operations while involving the appropriate functional groups in communications and decision making.
  • 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 (e.g. ISO 13485, EU MDR, etc.).
  • Support and perform internal and external audits as appropriate (e.g. 3PL, distributors, importers, OEMs, suppliers).
  • Delivery of appropriate Quality System training to associates and/or third-party employees according to business needs.
  • Initiate change documentation and prepare quality reports and presentations, including input to Trend Review Boards and Management Review.
  • Coordinate with and provide QA support to other regional and global functions (e.g. Distribution and Logistics, Customer Service, Sales Contracts, Regulatory, Product Surveillance Group, Labelling, Field Action Teams, etc.).
  • Assist in the development and execution of global and regional quality objectives and resource plans.

**Requirements:**

  • At least 4 years medical device or other life-science industry experience in developing, implementing, and maintaining quality systems.
  • Demonstrated strong technical capability.
  • Effective interpersonal skills with experience collaborating effectively across functions and establishing key relationships.
  • Knowledge of ISO 13485 and EU MDR.
  • Ability to multitask, prioritize, and meet deadlines.
  • Ability to work alone or as part of a diverse team.
  • Fluent in English with strong verbal and written communication skills.
  • Strong organizational skills and detail-oriented while being flexible and able to adapt to changing priorities.

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