Sam Tsai Email & Phone Number

1.Extensive Corporate Quality Management : - Over 20 years of hands-on experience in corporate quality management.2.Specialized in Supply Management and Quality Systems : - Focused expertise in supply management and comprehensive quality system implementation.3.Current Role as Head of Quality : - Currently serving as the Head of Quality, overseeing medical device products. - Responsibilities include managing the Quality Management System and Regulatory Affairs Certification.4.Certifications and Auditing Experience : - Certified in ISO9001, ISO13485, AS9100, and IATF 16949. - Accomplished internal auditor in Lean Manufacturing.5.6-Sigma Methodology and Production Optimization : - Successfully applied 6-Sigma Black Belt methodology. - Utilized value stream mapping to enhance production efficiency and ensure top-notch quality.6.Expertise in Reliability and Qualifications : - Proficient in reliability testing, process capability analysis, MSA, GRR and DOE. - Extensive experience in product qualifications ensuring high standards.

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  Quality Manager

  Avita Corporation

  Oct 2017 - Present - 中國 江蘇

  1)Established and maintained crucial processes for QMS.2)Applied trend analysis for continuous production line improvements.3)Managed labs, calibration and process verification/validation.4)Mentored QA/QC engineers, fostering a culture of continuous improvement.5)Led quality initiatives in new product development.6)Ensured regulatory compliance and effective customer complaint management.