Senior Global Design Assurance Engineer – Medical Devices

Greiner; Kremsmünster; On-site; EUR 55,000 - 67,000; Full time

Benefits offered by this job

Attractive social benefits

Job summary

Greiner in Austria is seeking a Quality Engineer to drive harmonized group-wide validation activities from a QM perspective across multiple business units and sites. The role focuses on Process, Method, and Sterilization validation, ensuring compliance and efficiency.

You will collaborate with cross-functional teams to promote Design Assurance Engineering activities, support process transfers, and assess impact of changes. Fluent English and strong German are required.

Qualifications

• Bachelor’s degree in life science or engineering with 2+ years relevant experience.
• 7+ years international quality engineering experience incl. FDA requirements.
• Process and radiation sterilization validation knowledge.
• 7+ years experience in the medical device industry.
• Understanding of QM processes and tools.
• Fluent English with very good German language skills.

Responsibilities

• Ensure harmonized group-wide validation processes (Process, Method, Sterilization) from a QM perspective across BUs and sites.
• Collaborate with cross-functional teams to promote Design Assurance Engineering activities in a compliant, efficient and risk-based manner.
• Ensure compliant and efficient implementation of process transfers.
• Conduct impact assessments of process changes.
• Review and approve global documents such as Master Validation Plan and Global Process Transfer Plan.

Skills

English proficiency

German proficiency

QA knowledge

Regulatory awareness

Education

Bachelor’s degree in Life Science or Engineering

Job description

Greiner in Austria is seeking a Quality Engineer to drive harmonized group-wide validation activities from a QM perspective across multiple business units and sites. The role focuses on Process, Method, and Sterilization validation, ensuring compliance and efficiency.

You will collaborate with cross-functional teams to promote Design Assurance Engineering activities, support process transfers, and assess impact of changes. Fluent English and strong German are required.