Bruker is one of the world’s leading analytical instrumentation companies enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Our high-performance products and high-value life science and diagnostics solutions are trusted by leading businesses, institutes, and scientists worldwide. 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)
Responsibilities
* provide quality engineering support in design, development, and sustaining activities for low, moderate and complex medical device (IVD) and other (RUO) products.
* Focus will be on quality engineering of design inputs, and design outputs like risk management files, and working closely with the production quality engineers for design transfer and sustaining engineering activities.
* Ability to digitize processes in standard tools (e.g., 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)
* Capable of mentoring junior level quality engineers in providing quality engineering support for their product lines and teams.
* 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.
Qualifications
* Sc. / B.A. in Engineering or a specific scientific field
* Minimum 5 years of experience in Quality Engineering
* Working knowledge of the requirements of FDA QSR, ISO 13485, and ISO 9001, IVDR, risk management (ISO 14971, D-FMEA, P_FMEA, RBA)
* Degree in engineering or related STEM field
* Strong design control understanding from concept to launch (e.g., product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied during the product development process)
* Competency in Process Validation (IQ, OQ, PQ), Control Plans, DOE, Statistical Process Control and Capability Analysis helpful
* Excellent verbal and written communication skills, in German and English
* 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
* Experience with electronic quality management systems (like MasterControl), and statistical tools (e.g., Minitab) are helpful
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