We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 9 years with our diagnostic products and patented technologies. Our products help clarify allergies in a single step – for humans and animals alike. Allergies are diagnosed with high specificity, enabling patients to receive help by their specialists in no time. We improve quality of life, enable personalized treatment, advance research, and relieve the burden on our healthcare system.

We offer:

• A full-time position, flexible working hours, home office if necessary
• Annual pass for Vienna's public transport and Sodexo vouchers
• Collaboration with people who care about human and veterinary patients alike
• An environment where you feel empowered to ask questions, make requests and offer ideas
• An atmosphere created by the thoughts of sustainability, equity, diversity, inclusion, and mutual respect

We need you for:

• Develop and maintain an integrated Quality Management System with the potential to enhance it to an integrated OHQS Management system and own all internal and external System and Product audits
• Ensure to be compliant with EN ISO 9001, EN ISO 13485, IVDR, MDSAP and FDA but avoid unnecessary overachievement by company specific regulations
• Ensure and maintain all certifications relevant for market entry and operations and manage the interface to the notified body and certification partner
• Increase the level of acceptance by developing a Compliance & Performance Management System
• Methodically develop business processes and responsibilities aligned with corporate strategy
• Scale and harmonize processes across international sites
• Support departments in process risk analysis (pFMEA), design and optimization (R&D, Order Management, Production, Procurement, Service & Support, Product Life Cyle Management, Sales & Distribution)
• Build and enhance an effective document control, distribution and archiving system (eQMS)
• Establish and maintain KPI systems to ensure effective and efficient processes and strategic deployment management (e.g., Hoshin Kanri, Balanced Scorecard), provide KPI reports, deviation analysis, and management information
• Ensure risk-based controls for suppliers, processes, inspections, and maintenance
• Keep a cross linked Continous Improvement Process in progress by follow up CAPA, RECLA, NCR, CR, SCAR, including Rout Cause Analysis and RPZ Assessments
• Closing the loop with lessons learned
• Lead and manage the QM team, including goal setting and competency development
• Train and advise leaders on quality management and compliance

Your Profile:

• Certified Quality Manager and Quality Auditor by an accredited training and education Institute
• Minimum 15 years of experience in quality management (e.g., Quality Manager, QM Consultant, standardization/normalization committees), proven internal and/or external audit experience
• Strong knowledge of regulatory requirements, ideally MedTech/IVD (EN ISO 13485, IVDR, etc.)
• Experience in cross-site process development and scaling in an international environment
• Strong methodological skills in process management, continuous improvement (KVP/Lean/Six Sigma), risk, and failure analysis (FMEA, pFMEArisk matrix) and Rout Cause Analysis (5W, ISHIKAWA) as well as preventive methodologies f.i. 5S, POKA YOKE,
• Confident with KPI systems
• Excellent written and spoken English and German
• Strong leadership skills (delegation, goal orientation, coaching)
• High moderation and communication skills
• Ability to motivate and influence others in order to sustainably embed quality initiatives

We offer a payment in line with collective agreement (KV Handwerk und Gewerbe) based on a full-time position. Your actual salary depends on your previous experience and qualifications. Ready to become part of the MADx team? Then apply with your CV via our website https://www.madx.com/career/jobs.