Quality & Process Consultant (f/m/d)

MacroArray Diagnostics

  • Wien
  • Unbefristet
  • Vollzeit
  • 1 Monat 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.We offer:
  • 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 athmosphere created by the thoughts of sustainability, equity, diversity, inclusion, and mutual respect
We need you for:
  • 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
Your profile:
  • 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
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!MacroArray Diagnostics GmbH

MacroArray Diagnostics