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Quality Engineer
Job Summary: Quality Engineer primarily support the performance of BIOLYPH’s Quality Management System (QMS) in alignment with BIOLYPH’s business model of producing our Clients’ IVD/RUO products Effectively, Efficiently, and Economically. Essential Job Functions: Support the performance of BIOLYPH’s Quality Management System (QMS) based on 21 CFR 820 and ISO 13485 Ensure clear policies, procedures, instructions, and forms exist to support production Provide measurement methodologies and assist in problem-solving activities Production Support and Monitoring: Develop quality plans, such as FMEAs, Control Plans, and SPC, when required Ensure processes in use are appropriatel
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