Design Quality Engineer I m/f/d
Minimum of a Bachelor’s Degree in an engineering or science field, or equivalent work experience
Several years of hands-on experience; pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current good manufacturing practices, quality system regulations, and ISO standards
Specific experience in medical device design controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design input
Specific experience designing, preparing, executing, and statistically analyzing validations as well as developing report packages to approve equipment, processes, methods and software
Partner with R&D and other cross-functional groups to support-successful development and commercial launch of new products
Partner with R&D and other cross-functional groups to support the proper application of design controls, process validation, risk management, and the investigation / correction of design failures / challenges
Support the execution of design verification / validation protocols to demonstrate the design output fulfills the design input requirements
Provide hands-on support to validate test methods
Active participation in an international quality team
Intensive training with mentoring program
Diverse benefits such as hybrid working, business bike, company pension and subsidy for our canteen
Partner with R&D and other cross-functional groups to support the proper application of design controls, process validation, risk management, and the investigation / correction of design failures / challenges
Support the execution of design verification / validation protocols to demonstrate the design output fulfills the design input requirements
Provide hands-on support to validate test methods
Minimum of a Bachelor's Degree in an engineering or science field, or equivalent work experience
Several years of hands-on experience; pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current good manufacturing practices, quality system regulations, and ISO standards
Specific experience in medical device design controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design input
Specific experience designing, preparing, executing, and statistically analyzing validations as well as developing report packages to approve equipment, processes, methods and software