Global Design Assurance Engineer - Validation & Transfers

Greiner; Schürzendorf; Vor Ort; EUR 55.000 - 67.000; Vollzeit

Zusammenfassung

Greiner in Austria seeks a senior Quality Engineer to drive harmonized validation processes (Process, Method, Sterilization) across units. You will collaborate with cross-functional teams to promote Design Assurance activities and ensure efficient transfer implementations and impact assessments of changes.

The role requires 7+ years in medical device quality engineering, fluency in English and strong German, and a Bachelor’s in a life-science or engineering field, with a salary above the

Qualifikationen

• Bachelor’s degree in a life-science or engineering field, or completed education with a minimum of two years of relevant professional experience
• 7+ years of international quality engineering experience including FDA requirements
• 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

Aufgaben

• Ensure compliant and efficient harmonized validation processes across Business Units and sites
• Collaborate with cross-functional teams to promote and ensure 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)

Kenntnisse

Quality engineering

FDA requirements

Process validation

Sterilization validation

Medical device industry

Initiative

Cross-cultural experience

English; German

Ausbildung

Bachelor's degree in life-science or engineering

Jobbeschreibung

Greiner in Austria seeks a senior Quality Engineer to drive harmonized validation processes (Process, Method, Sterilization) across units. You will collaborate with cross-functional teams to promote Design Assurance activities and ensure efficient transfer implementations and impact assessments of changes.

The role requires 7+ years in medical device quality engineering, fluency in English and strong German, and a Bachelor’s in a life-science or engineering field, with a salary above the