Apply for the Head of Quality Management (f/m/x) at MADx – Macro Array Diagnostics GmbH.
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
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 compliance 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 Root 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 Root Cause Analysis (5W, Ishikawa) as well as preventive methodologies such as 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.
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