Senior Expert Global Design Assurance Engineering (all genders)
Company: Greiner Bio-One International GmbH
Location: Kremsmünster
Employment Type: Permanent
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 +43 664 8892 0539.
If you are passionate about promoting innovative medical devices and possess the skills and experience outlined above, we encourage you to apply for this exciting opportunity to join our dynamic team at GBO. Please submit your resume and cover letter detailing your relevant experience and qualifications. We look forward to hearing from you!
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.
- Training and Further Development
- Pension Fund
- Company doctor*
- Lunch Allowance
- Health Measures
- Flexible Working Hours*
- Parking*
- Childcare Services*
- Company Events
- Discounts
- Variable Compensation*
- Home Office*
- Supplementary Insurances
- Job bike
- Transportation Allowance
*Depending on location and/or position
About Greiner Bio-One
Greiner Bio-One feels like home.
For visionaries with drive and ideas, for team players who share their knowledge and entertain new ways of thinking, for people whostrive for excellence. Our door is always open to achievers, doers and hidden talents who want to make a difference.
We have future in our blood.
Job ID: 4368
Apply now »