Regional Quality Assurance Engineer (F/M/D)

Regional Quality Assurance Engineer (f/m/d)About the Role: We are looking for a Regional Quality Assurance Engineer (f/m/d) to join the EMEA Regional Quality Assurance team to support our operations in the EMEA region. In this role, 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, including the creation of 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. You will also provide general support to other RQAs in support of regional quality activities as necessary. This position will be located at our facility in Barcelona, Spain, with work from home days possible as part of a hybrid arrangement, depending upon the responsibilities of the role and business needs.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.Understand regional regulatory needs and requirements, providing 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).Deliver appropriate Quality System training to MPD 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.About the CompanyW L Gore & Associates, Inc. is an American multinational manufacturing company specializing in products derived from fluoropolymers.
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