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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
[Áö¿ø
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-E-mail Áö¿ø : ******@*******.***
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