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[Position]

Quality Engineer (´ë¸®~°úÀå±Þ)

 

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[Role]

¡¤       Lead and support key quality activities for new product development and design transfer to manufacturing

¡¤       Collaborate with manufacturing, engineering and regulatory functions to ensure quality standards are met

¡¤       Develop, modify and maintain quality system procedures and support internal or external audit activities

¡¤       Analyze, scope, and lead key continuous improvement projects

¡¤       Lead CAPA projects and assist with post market analysis

¡¤       Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations

¡¤       Design or specify inspection and testing equipment and conduct quality assurance tests

¡¤       Investigate nonconforming product or process quality issues, recommend solutions for decision and drive implementation of the solutions.

¡¤       Ensure safety and compliance with applicable regulations and industry standards

 

[Qualifications]

¡¤       Bachelor¡¯s degree in engineering, science or technical field with 5+ years of work experience in engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality

¡¤       Proficiency in written and spoken English

¡¤       Experience in Quality roles developing, modifying, and maintaining quality system procedures and supporting internal or external audit activities

¡¤       Demonstrated knowledge of applying quality engineering methodologies for manufacturing high-quality products

¡¤       Demonstrated knowledge of Root Cause Investigation, Corrective and Preventive Actions, Risk Assessment, statistical data analysis

 

[Preferred Qualifications]

¡¤       Knowledge and experience in digital health and wellness devices

¡¤       Master¡¯s degree in engineering, science or a technical field

¡¤       Experience in testing, including cosmetic and dimensional characterization, physical (mechanical/electrical) testing, and simulated use testing

¡¤       Proficiency with statistical tools and the ability to perform statistical analysis of product and test data

¡¤       Experience implementing, or working within Quality Management Systems (e.g., ISO 9001)

¡¤       Demonstrated ability to translate regulations and industry standards to internal processes/systems and implement them across the organization effectively

¡¤       A proven track record of developing engineering solutions for complex problems

¡¤       Product launch experience from early prototypes to production and commercialization

¡¤       Excellent communication skills, both written and verbal

 

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-E-mail Áö¿ø : ******@*******.***

 

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