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Regional Quality Assurance Specialist
hace 2 meses
We are seeking a highly skilled Regional Quality Assurance Specialist 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:- Process Development and Improvement: 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.
- NCR/CAPA Management: Initiate NCR/CAPA activities as required, including identification of root cause, action planning, and post-implementation effectiveness checks.
- Regulatory Compliance: Understand regional regulatory needs and requirements, providing input to gap analysis of regulation updates (e.g. ISO 13485, EU MDR, etc.).
- Audit Support: Support and perform internal and external audits as appropriate (e.g. 3PL, distributors, importers, OEMs, suppliers).
- Quality Training: Deliver appropriate Quality System training to associates and/or third-party employees according to business needs.
- Reporting and Presentations: Initiate change documentation and prepare quality reports and presentations, including input to Trend Review Boards and Management Review.
- Interdepartmental Collaboration: 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.).
- Quality Objectives and Resource Planning: Assist in the development and execution of global and regional quality objectives and resource plans.
W. L. Gore & Associates is a multinational manufacturing company specializing in products derived from fluoropolymers. Our company values innovation, quality, and customer satisfaction, and we are committed to maintaining the highest standards in our industry.
