Design Quality Engineer II (m/f/d)
22.04.2025
JOTEC GmbH
Hechingen
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22.04.2025, JOTEC GmbH
Hechingen
Design Quality Engineer II (m/f/d)
Aufgaben:
Partner with R&D and other cross-functional groups to support the 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
Review and approve design input requirements as appropriate
Review and approve the translation of design input requirements into design output documents
Establish and/or maintain risk management files to support product lines and corporate projects
Review and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements
Review, approve, and validate test methods
Conduct investigations, documentation, review, and approval of non-conformances, CAPAs and customer complaints as necessary
Qualifikationen:
Minimum of a Bachelor's Degree in an engineering or science field, or equivalent work experience
Several years of hands-on experience; preferably in an FDA / MDR regulatory industry (i.e., 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
Goal-oriented team player with an open mind and a high level of adaptability, eager to embrace new ideas quickly
Ability to work independently with minimal supervision
Berufsfeld
Standorte