Überblick
Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with customers, Bruker is enabling innovation and customer success in post-genomic life science molecular and cell biology, in disease biology and translational research, in specialty diagnostics, in applied and biopharma applications, as well as in industrial and cleantech research and QC, and in next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology, molecular diagnostics and therapeutic drug monitoring. For more information, please visit .
Today, more than 11000 employees at over 90 locations are working on this permanent challenge to make the world a better place.
For our quality management team in Bremen we are looking for a "Senior Quality Engineer (m/w/d)".
Aufgaben/Verantwortlichkeiten
1. provide quality engineering support in design, development, and sustaining activities for low, moderate and complex medical device (IVDs).
2. Focus will be on supporting post-merger integration of M&A targets.
3. Ability to digitize processes in standard tools (., MasterControl), also across several sites, and participate in the development of the company's IT strategy (CRM, ERP, quality management tools like MasterControl, and document and record repository strategy).
4. Capable of mentoring others in the organisation (in particular, the acquired one) is a key success factor.
5. This position may be called upon to provide support for operations and quality systems by assisting in the development and implementation of quality policies and procedures.
Qualifikationen
6. Bachelor degree (or higher) in engineering or a specific scientific field
7. Minimum 5 years of experience in quality engineering
8. Working knowledge of the requirements of FDA QSR, ISO 13485, and ISO 9001, IVDR, risk management (ISO 14971, D-FMEA, P_FMEA)
9. Strong design control understanding from concept to launch (., product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied during the product development process)
10. Competency in process validation (IQ, OQ, PQ), control plans, DOE, statistical process control and capability analysis helpful
11. Excellent verbal and written communication skills, in German and English
12. Multi-year (5y+) previous experience working in a regulated or medical device development environment as well as in working in a cross-functional team environment
13. Experience with electronic quality management systems (like MasterControl), and statistical tools (., Minitab) are helpful