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• Overall responsibility: Manage MOPD elements for new initiatives (Stream I, II, III, IV) and critical processes with impact on consumer relevant product characteristics during the complete lifecycle to enable development and delivery of processes that consistently give the desired outputs (in-control, capable, and on-target). • Required Skills o Mastery in FMEA/FMECA and Risk Management, able to lead FMEA process end to end (Concept, Design, Process) and create Risk Analysis and Assessment based on FMEAs o Mastery in Product Design Validation, and MOPD ¨C Methodology of Process Development including both process development and process qualification (Transformation Flow Sheet, Process Control Strategy, IQ/OQ/PQ, etc.). o Mastery in SPC ¨C Statistical Process Control and targeting statistics o Familiar with device/small appliances design and development process, ideally with Mechanical Design or Electronic Design background, or with Master or PHD degrees in Engineer, Physics or other technical discipline. o Good English and Chinese language proficiency (both written and oral), good project management skill and communication skill are required, as this role is expected to partner with global multi-functional teams to create the FMEAs and design/process qualification strategy. o Knowledge on ISO 13485, 9001, FDA CFR 820 is a plus point. ¸ÐÐËȤ¿ÉÁªÏµ13127792169£¨Í¬Î¢ÐÅ£©£¬»ò·¢ËͼòÀúÖÁ13127792169@163.com |
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