Role DescriptionIn your position as Senior Software Quality Specialist, your main focus is the maintenance, improvement and development of the Quality department for the site in Belgium. You will be operating with a Quality Management Systems according Software standards. You are a key contact person when it comes to issues and questions in relation the QMS for both internal and external stakeholders. You will be involved in creating training and the development of strategies and activities regarding quality. On a local level, you will interact with various departments among which Marketing, R&D, and the Manufacturing. Furthermore, you will be closely collaborating with international sites to ensure global alignment.
ResponsibilitiesAs mentioned previously, you will overview and control all activities concentrated on the improvement of the Quality Department in alignment with other disciplines within the organisation. Furthermore, you are responsible for: • Guidance and support to team members and various stakeholders across the organisation • Ensuring that nonconformities are identified, performing GAP analyses, executing CAPA’s and implementing strategies of improvement • Implementation, development and maintenance of ISO and FDA standards, in particular ISO 13485, IEC 62304, IEC 60601, IEC 62366,ISO 27001 and FDA QSR 820 • Taking responsibility during internal and external audits • Offer assistance to RA practices such as the 510k submission, document control and CE IVD DOC • Defining Key Performance Indicators for the EMA Quality Logistic site • Checking test equipment for sufficient calibration and verification which should be suitable for specific verification and testing activities • Development of training activities and execution • Key contact person for all issues and questions related to the QMS
Requirements• Bachelor or Master in Life Sciences • Minimal 5 years of experience in Quality Assurance within the Life Sciences industry • Excellent knowledge of ISO 13485, 21 CFR Part 820, ISO 14971 and ISO 27001, and preferably IEC 60601, IEC 62304 and ISO 62366 • Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders • Individual operator yet team player • Excellent analytical and problem-solving skills • Fluency in English and Dutch • Strong communication skills and excellent negotiating skills • Ability to travel around 5-10%
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.