Senior Expert Global Design Assurance Engineering (all genders)

Greiner Bio-One International; Frickenhausen; Presencial; EUR 55 000 - 67 000; Tempo integral

Resumo da oferta

Greiner Bio-One International in Frickenhausen, Germany, seeks a Quality Engineering professional to harmonize validation processes (Process, Method, Sterilization) group-wide from a QM perspective across business units and sites. This role emphasizes regulatory compliance and risk-based thinking within medical device environments.

In collaboration with cross-functional teams, you will promote and drive Design Assurance activities, assess process transfers, and approve global documents such as

Qualificações

• Bachelor's degree in life-science or engineering with at least two years relevant experience.
• 7+ years international quality engineering including FDA requirements.
• Process and radiation sterilization validation knowledge.
• Experience in the medical device industry (7+ years).
• Understanding of QM processes and tools.
• Ability to take initiative and work independently.
• Fluent in English and strong German skills.

Responsabilidades

• Ensure compliant harmonized validation processes across groups and sites (Process, Method, Sterilization).
• Collaborate to promote and execute Design Assurance Engineering activities in a compliant, efficient, risk-based manner.
• Ensure compliant implementation of process transfers.
• Perform impact assessment of process changes.
• Review and approve global documents like Master Validation Plan and Global Process Transfer Plan.

Conhecimentos

Quality engineering

FDA requirements

Process validation

Sterilization validation

Medical device industry

English proficiency

German language

Formação académica

Bachelor's degree life-science or engineering

2+ years relevant experience

Descrição da oferta de emprego

• 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.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.