Senior Expert Global Design Assurance Engineering (all genders)

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

• 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 [phone].

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