Our 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 accountability Create and maintain quality related documentation ., Device Master Record, Quality plan, Control plan, Quality record, local quality instructions Quality approval and release of products Handle non-conforming products incl. control of returned goods incl. handling and reporting in TrackWise and handling of lot status in E1 Handling of CAPA (initiations, root cause investigations and evaluation of effectiveness) Handling of Quality related change request tasks in the projects through Change Control procedure Distribute product drawings to the production Support Head of Quality in data gathering for Quality Management Reviews Support implementation of new machines and Item transfers with quality related tasks Participate in both internal and external audits Implementation, 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 Qualifications Bachelor's degree in Industrial Engineering, Quality, Production, Chemistry or equivalent Minimum 2 years of experience within medical device or manufacturing industry with thorough knowledge of methodologies of quality assurance and standards Minimum 3 years of experience in Quality related roles Knowledge 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, SharePoint English (minimum B1 level) reading, writing, and speaking in a conversational level Functional 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. Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.
