Corrections and Removals Specialist IGT Systems

Are you ready to ensure product quality and customer satisfaction?

• BS in a Technical Discipline preferably in Healthcare, Engineering or Science;
• 6+ years of related experience in a medical device or regulated industry preferably in Correction and Removal processes, regulatory submission, Risk Management;
• Project Management skills. 2+ yeas of project management is an advantage;
• In-depth knowledge of Quality management systems and deep understanding of related regulation (e.g. 21 CFR Parts 803, 806, and 820, EU MDR – Regulation (EU) 2017/745, ISO 13485, ISO 14971, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169). Proven work experience is preferable;
• Good analytical skills and process improvement capabilities;
• Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers);
• Ability to successfully balance and prioritize multiple ongoing projects/tasks;
• Strong attention to detail and accuracy;
• High reliability and quality focus;
• High degree of initiative, engagement, self-motivation and flexibility;
• Able to work in a changing environment and be a full supported of change.