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Quality Engineer

Company

Sartorius

Location

Songdo, United States

Type

Full-time

Performs end-to-end quality activities across manufacturing processes, starting from equipment URS review through validation/qualification, PPQ, and in-process control, to support stable production.


The Quality Efficiency Professional will be responsible for designing and continuous improving of the core processes in quality management and the strategic assurance of quality-related method standards in projects and daily business. The holder of this position will focus is on the further development, implementation and training of quality methods.


Main Responsibilities & Tasks:

+ Collaborate with process owners to establish Qualification and Validation strategies across the full lifecycle of equipment and manufacturing processes (URS, DQ, FAT, IQ, OQ, PQ, PPQ), ensuring compliance with requirements and regulations.

+ Conduct and document risk assessments for systems, processes, and products using risk‑management tools such as FMEA and Impac...

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