Experience with QSR, GMP, ISO 14971 and ISO 13485, and EU MDR; risk management experience in the medical device manufacturing industry; manufacturing andor development environments with medical device; manufacturing quality toolset such as PFMEA, control plans, GRR, GDT; new product development; and, Process Validation IQOQPQ protocols, and reports.br br H.4H.10 Masters degree or foreign equivalent in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or in a related process design engineering field and three 3 years of experience in manufacturing engineering in the pharmaceutical industry or a related role.

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