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Product & Process Engineer (Biomedical)
Hiredly XKuala Lumpur, MY30+ hari lalu
Penerangan pekerjaanTake on full responsibility for the coordination and management of all equipment and process IQ’s, OQ’s and PQ’s -Monitor and improve BIOVIC’s manufacturing processes with respect to yield and throughput -Coordinate and manage all production process validations -Coordinate and manage process validations of new products and line extensions -Assist with increasing production capacity by streamlining and wherever possible automating manufacturing processes -Keep all process FMEAs up to date [Apply now at https : / / my.hiredly.com / jobs / jobs-malaysia-hiredly-x-job-product-process-engineer-biomedical] Candidate must have at a minimum a bachelor’s degree in an engineering or science discipline -At least 4-5 years’ work experience in this field required; medical device background preferred -Experience with ISO 13485 quality system is required, product / process FMEA will be a plus -Must be able to understand and familiarize oneself with company’s multi-step manufacturing process (training will be provided). -Must be familiar with writing and performing equipment and process IQ’s, OQ’s and PQ’s -Must be familiar with writing and running process validations -Must be comfortable with basic statistics and statistical software, familiarity with Design of Experiments is preferred -Must demonstrate proficiency with following SOP’s, and must have good attention to detail. -All protocols and reports must be in English, as such excellent spoken and written -English skills are required. -A diverse skillset is preferred as we work as a team, and may need to assist other departments
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Product Engineer • Kuala Lumpur, MY