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Quality & Process Consultant (f/m/d)
Posted 13 hours 4 minutes ago by MacroArray 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 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.
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
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 , 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!
JBG81_AT
MacroArray Diagnostics GmbH
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