Ensuring compliant and efficient harmonized group-wide validation processes (Process, Method, Sterilization) from a QM perspective across Business Units (regulated and non-regulated products) and sites. Collaborating with cross-functional teams to promote and ensure the execution of Design Assurance Engineering activities in a compliant, efficient and risk-based manner Ensure compliant and efficient implementation of process transfers Impact assessment of process changes Quality review and approval of global applicable documents, e.g. Master Validation plan, Global Process Transfer plan, process changes Your challenge
Ensuring compliant and efficient harmonized group-wide validation processes (Process, Method, Sterilization) from a QM perspective across Business Units (regulated and non-regulated products) and sites. Collaborating with cross-functional teams to promote and ensure the execution of Design Assurance Engineering activities in a compliant, efficient and risk-based manner Ensure compliant and efficient implementation of process transfers Impact assessment of process changes Quality review and approval of global applicable documents, e.g. Master Validation plan, Global Process Transfer plan, process changes Your Profile
Bachelor’s degree in a relevant life-science or engineering field or completed education with a minimum of two years of relevant professional experience Proven experience in international quality engineering including FDA requirements (7+ years) Process and radiation sterilization validation knowledge Proven experience in medical device industry (7+ years) Understanding of state-of-the‑art QM processes and tools Ability to take initiative and work without close supervision Experience with international companies/cultures of great advantage Fluent in English and very good skills in German Our Offer
We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 60.977,70 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment. If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539. Profile description: Not applicable for interfaces
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Senior Expert Global Design Assurance Engineering (all genders) in Kremsmünster Arbeitgeber: Greiner
Als familiengeführtes Unternehmen in Pleidelsheim bieten wir eine inspirierende Arbeitsumgebung, die von Teamgeist und Innovation geprägt ist. Unsere Mitarbeiter profitieren von kurzen Entscheidungswegen, einem hohen Maß an Eigenverantwortung und der Möglichkeit, aktiv an der Weiterentwicklung unserer Qualitätsmanagementsysteme mitzuwirken. Wir fördern eine Kultur der kontinuierlichen Verbesserung und bieten zahlreiche Chancen zur persönlichen und beruflichen Weiterentwicklung in einem dynamischen Umfeld.
