Quality Systems Engineer

Our client are a world-leading developer and manufacturer of innovative medical technology and devices. They have global presence and offer a wide range of surgical products, brand as well as private-label products.Since 2019, the group has made several acquisitions across the UK and Europe. Products are sold worldwide through a network of multinational or regional partners and distributors, as well as through direct sales. The group has R&D innovation centers looking to continually innovate.They are looking to add a Quality Systems Engineer to the team base in Bavaria, Germany to ensure compliance. Position:Prepare and support in the execution of external audits by Notified BodiesConduct and follow-up of internal auditsTraining colleagues on quality topics, updated SOPs, and GMP requirementsCreation and updating of QMS SOPs as well as supporting other departments (including across locations)Participation in quality management projects (e.g., implementation of MDR requirements, group-wide SOPs, country-specific MDSAP requirements)The Quality Systems Engineer will support and represent in change & CAPA processesParticipation in Non-Conformity and ComplaintsSupport Group Regulatory Affairs in the product registration of medical devices, especially within the scope of the MDR but also worldwideIndependent data collection and analysis, e.g., for approval purposesSupport of new product development in (quality)Qualifications:The Quality Systems Engineer will ideally have a Degree level education or track record in Quality SystemsProduction Site Exposure in medical device, pharmaceuticals, or GxP sectorsKnowledge of ISO 13485, MDD, MDR, and MDSAPCAPA, non-conformance, and complaint handlingIdeally training as an internal auditorGerman & English Language & Writing skillsDesirable:Knowledge in risk management (ISO 14971)Change controlThis is a fixed term contractbetween 12-24 months Desired Skills and Experience Quality Systems, medical device, ISO 13485, MDD, MDR, and MDSAP, CAPA, non-conformance, and complaint handling, auditing, German & English