Global Design Assurance Engineer - Validation and Transfers

Greiner Bio-One International; Schürzendorf; Vor Ort; EUR 55.000 - 67.000; Vollzeit

Zusammenfassung

Greiner Bio-One International seeks a senior specialist to ensure compliant, harmonized group-wide validation processes focused on process, method and sterilization from a QM perspective across sites. You will collaborate with cross-functional teams to drive Design Assurance activities, implement process transfers, and assess changes to quality impact.

The role demands a Bachelor’s degree in life-science or engineering, 7+ years in international quality engineering with FDA exposure,

Qualifikationen

• Bachelor's degree in life-science or engineering.
• 7+ years international quality engineering with FDA considerations.
• Process and radiation sterilization validation knowledge.
• Medical device industry experience (7+ years).
• Strong QM processes and tools understanding.
• Initiative and ability to work autonomously.
• Experience with international companies/cultures is advantageous.
• Fluent English and very good German skills.

Aufgaben

• Ensure compliant, harmonized group-wide validation processes across units/sites.
• Collaborate with cross-functional teams to promote Design Assurance activities.
• Ensure compliant implementation of process transfers.
• Impact assessment of process changes.
• Quality review/approval of global documents (Master Validation plan, Global Process Transfer plan).

Kenntnisse

Quality engineering

FDA regulatory knowledge

Process validation

Medical devices

Quality systems

Initiative

International experience

English

German

Sterilization validation

Ausbildung

Bachelor's degree in a relevant life-science or engineering field

Jobbeschreibung

Greiner Bio-One International seeks a senior specialist to ensure compliant, harmonized group-wide validation processes focused on process, method and sterilization from a QM perspective across sites. You will collaborate with cross-functional teams to drive Design Assurance activities, implement process transfers, and assess changes to quality impact.

The role demands a Bachelor’s degree in life-science or engineering, 7+ years in international quality engineering with FDA exposure,