Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Barrington JamesRecruitment Consultant | Quality Assurance | UK & EuropeJob Summary:An innovative medical device manufacturer, part of a dynamic global medtech group, is on the lookout for a driven quality expert to lead QA and RA activities at their site in Weil am Rhein, nestled in the vibrant south of Germany. This is your chance to shape compliance across the entire product lifecycle while ensuring robust systems aligned with international standards such as ISO 13485, MDR, and FDA requirements.Key ResponsibilitiesChampion compliance across both Design Quality Assurance (DQA) and Manufacturing Quality Assurance (MQA) in line with ISO 13485, MDR, and FDA 21 CFR Part 820Manage and continually enhance the Quality Management System (QMS), overseeing the creation and upkeep of SOPs, work instructions, and controlled documentsAct as a primary contact for internal and external audits, including those by the FDA, Notified Bodies, and global clientsOwn CAPA processes, handle deviations, non-conformances, and change controls with a proactive mindsetGuide updates to technical documentation to ensure EU MDR and FDA complianceDrive and support risk management (FMEA), process validations, and controls within manufacturingWork hand-in-hand with R&D and production to maintain quality standards throughout the product lifecycleEducate and advise teams on regulatory expectations and internal QA/QM systemsSupport worldwide submissions and regulatory strategies in coordination with headquartersCollaborate with the corporate quality team to harmonize quality approaches across all sitesWhat We're Looking For:A degree in Life Sciences, Medical Technology, Quality, Regulatory Affairs, or a similar field (or an equivalent professional background)Solid experience in medical devices or other regulated industries (ideally 2+ years)Strong grasp of ISO 13485, MDR, 21 CFR 820, and general quality system frameworksHands-on experience with tools like TrackWise, SAP, SharePoint, or other QMS/ERP systemsFluency in German and English, both written and spokenA confident communicator with excellent documentation skills and an analytical mindsetWhy Apply?Be part of a young, energetic team at a growing international medical technology companyTake ownership in a pivotal role with high visibility and direct impact on quality and regulatory projectsEnjoy a modern, flexible work environment with hybrid options and advanced digital toolsBenefit from a competitive salary, 30 vacation days, and a strong pension planHigh degree of autonomy with the opportunity to shape quality strategies across multiple departmentsReady to take the next step in your QA/RA career and join a thriving MedTech team in southern Germany? We’d love to connect!Apply now or reach out for more details:Seniority levelSeniority levelAssociateEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at Barrington James by 2xGet notified about new Quality Assurance Manager jobs in Baden-Württemberg, Germany.Quality Assurance Associate Manager (m/f/d) Medical DevicesSenior Quality Assurance Manager (w/m/d) Process ValidationQA Manager (m/w/d) als Consultant GMP-Compliance in der Pharma / Biotech / Healthcare IndustrieQA Batch Processing Manager, Qualified Person (m/w/d)Quality Assurance Manager GCP/GVP (m/w/d)(Junior) ITSM Performance & Quality Manager (m/w/d)(Junior) ITSM Performance & Quality Manager (m/w/d)Test Manager (m/w/d) (H/F) - AIRBUS SECURE LAND COMMUNICATIONS GMBHSenior / Staff Quality Engineer (m/f/d) Navigation Medical DevicesIT Inhouse Consultant Production & Quality Management (m/w/d)We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr