Quality & Process Consultant (f/m/d)

MacroArray Diagnostics

  • Wien
  • Unbefristet
  • Vollzeit
  • 1 Tag her
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 clarifying allergies in a single step – for humans and animals alike. Allergies are diagnosed in a highly specific manner so that patients receive help by their specialist in no time. We increase quality of life, enable personalized treatment, advance research and relieve our health system.Ihre Aufgaben
  • Lead and support process mapping, reengineering, standardization, and documentation for operational excellence
  • Drive process adoption and quality improvement initiatives in compliance with ISO 9001, ISO 13485, IVDR
  • Apply Root Cause Analysis, Risk Analysis, and statistical methods to ensure quality assurance and control
  • Provide training and guidance on new tools, procedures, and quality standards
  • Collaborate with stakeholders to ensure smooth implementation and user adoption
  • Identify and analyze data to monitor process performance and quality metrics; use dashboards and KPIs for tracking
  • Prepare clear reports and recommendations for leadership based on findings and performance analysis
  • Drive cross-functional quality projects with clear timelines and documentation
  • Conduct internal audits and support external audits and certifications
Ihr Profil
  • Degree in a natural science field and certification in Quality Management (e.g., ISO 13485, MDSAP, IVDR)
  • 5 years of professional experience in Quality Management, Quality Assurance, or Process Improvement—ideally in a regulated environment
  • In-depth knowledge of relevant standards and regulatory requirements (e.g., ISO 9001, ISO 13485, MDSAP, IVDR, VDA, ISO 14001, ISO 45 000, ISO 27000)
  • Proficient in continuous improvement and problem-solving methodologies (e.g., CAPA, 8D, FMEA, 5W, RPZ, Six Sigma, PDCA, STATISTIK)
  • Confident user of an ERP/workflow systems (e.g., BMD, Salesforce), Microsoft Office, and process modeling tools
  • Skilled in presenting complex topics clearly and delivering effective training sessions
  • Experience in Customer Services / Sales / Relation Processes (e.g., helpdesk, training programs, company academies, key account support)
  • Strong analytical mindset, structured work approach, hands-on attitude, and excellent communication and collaboration skills
Wir bieten
  • A permanent full-time position
  • Annual pass for Vienna's public transport and Pluxee vouchers
  • Collaboration with people who care about human and veterinary patients alike
  • An environment where you feel empowered to ask questions, make requests and shape the company´s further path
  • An atmosphere created by the thoughts of sustainability, equity, diversity, inclusion, and mutual respect
For the cooperation in our team, we offer a payment in line with collective agreement (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!

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