**Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa RicaOur Quality Engineer ensures compliance to external and internal quality requirements and provides support to Operations value stream in accordance with Coloplast Quality Management System.Major areas of accountabilityCreate and maintain quality related documentation e.g., Device Master Record, Quality plan, Control plan, Quality record, local quality instructionsQuality approval and release of productsHandle non-conforming products incl. control of returned goods incl. handling and reporting in TrackWise and handling of lot status in E1Handling of CAPA (initiations, root cause investigations and evaluation of effectiveness)Handling of Quality related change request tasks in the projects through Change Control procedureDistribute product drawings to the productionSupport Head of Quality in data gathering for Quality Management ReviewsSupport implementation of new machines and Item transfers with quality related tasksParticipate in both internal and external auditsImplementation, training and follow up in relation to continuous improvements, including participation in RCA.Provide sparring and support to Global Operations incl. Global Quality and help improve the overall quality understanding and support of Lean activities.Essential QualificationsBachelor's degree in Industrial Engineering, Quality, Production, Chemistry or equivalentMinimum 2 years of experience within medical device or manufacturing industry with thorough knowledge of methodologies of quality assurance and standardsMinimum 3 years of experience in Quality related rolesKnowledge of statistical/data analysis and report writing experience.Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.Experience with Microsoft office package, E1, TrackWise, Meridian, Cognos, SharePointEnglish (minimum B1 level) reading, writing, and speaking in a conversational levelFunctional Competences*Quality Systems & Processes (3)Statistical Analysis & Tools (2)Technical Writing & Documentation (3)Regulatory Landscape, Standards & Regulations (2)System & Data Management (3)Validation (2)Design Control (2)Cross Functional competencies*Business Understanding (2)Project Management (2)Self-Management / People Development (2)Decision-making (3)Collaboration (3)Communication (3)Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.Watch the film. Follow us on LinkedIn. Like us on Facebook.56361LI-CO
