Senior Expert Global Design Assurance Engineering (all genders)

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

Job description:

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 [phone].

Profile description

Not applicable for interfaces