Senior QM Medical Device Officer

Role Overview

• Participate in the development of a quality management system for medical devices and combination products in accordance with applicable standards and regulations, i.e. ISO 13485, EU MDR regulation and US-FDA 21 CFR Part 4 and 820 and provide leading assistance in the preparation for company certification if necessary
• Ensure that the quality management system remains up to date, covering the current requirements of the above legislation relating to the combination of products and medical devices
• Provide assessment and support R&D and rest involved departments in quality management issues related to combination products and medical devices
• Participate in supplier audits whether it is necessary providing input in the compilation of the audit report
• Participate in audits/ inspections performed by customers, authorities and notified bodies supporting tasks related to combination products and medical devices
• Represent cQM and monitors the effectiveness of quality management tools in R&D and rest involved departments projects
• Answer to customer enquiries around medical devices and regulations for quality-relevant topics
• Communicate with medical device suppliers to monitor their changes and support the evaluation of the impact of such changes to company’s combination product
• Assist in response to Audit observations related to QMS activities of medical device/ combination products
• Assist in the development of documentation and record resulting from quality management system activities and according to established procedures including DHF
• Develop and adhere to strict project timelines
• Actively participate in multiple customer projects to support submission and launch preparation in different markets and communicate with suppliers for any specific requirement
• Participate in supplier evaluation processes reviewing and commenting on relevant documentation
• Participate in the review of Development/ Supply/ Quality Agreements and provide input
• Participate in the review of DHF documentation compiled by R&D Device Team

Requirements

• BSc/ MSc in Engineering, Chemistry, Pharmaceutical Sciences or another relevant sector
• Minimum 3 years of experience in Quality Management/ Assurance within the pharmaceutical industry preferred
• Good understanding of quality regulations ISO 9001, ISO 13485, and MDR will be considered an asset
• Fluency in English language (writing & speaking)
• Computer Literacy
• Ability to prioritize and meet deadlines
• Exceptional communication skills
• Strong project management skills

Benefits

• Involvement in a high-caliber, team-oriented and dynamic atmosphere
• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business/ scientific knowledge and skills