Brian Liang

Background

About Brian Liang

Strong Quality/Regulatory background with extensive experience in Quality operations, Regulatory compliance, Supply chain operations, Global quality system standardization and deployment as well as Business and Quality technology transformations programs. Proven leadership with a strong track record of delivering results in positions of increasing organizational capability, diversity, and performance- Self-motivated and dynamic business leader with over 15 years of experience in various industries (medical device, cosmetic, drug, injection molding, consumer, and military products) from small start-ups to large global corporations- Leading cross-functional team for various improvement project including defect reduction using statistical process control (SPC), optimize operation by improving facility layout, introducing lean process or automation, equipment capability analysis, and material and information flow- Hands-on experience in managing global and site-specific deployment on policies, standards, processes, business and quality software applications (Agile, SAP, Trackwise, Windchill and ARIS). UEDUCATION AND TRAINING MS of Materials ScienceUniversity of Southern California (USC), CA, USA BS of Materials EngineeringNational Cheng Kung University (NCKU), Tainan, Taiwan Certified CQA, CQE, SSGB, and SSBB through ASQ (All certifications are active) Certified Philips Six Sigma Black Belt and Lead Auditor Strong knowledge of 21CFR820, 21CFR211, MDSAP (TGA, ANVISA, MHLW and PMDA, FDA, HC), EU MDR, UDI, GMP as well as ISO14971, ISO13485, ISO9001, ISO22716 GMP Certification Over 150 hrs. QMS training including cGMP, MDD, FDA QSR, ISO13485, ISO9001, ISO14971, and ISO2271 Over 100 hrs. technical training for process and software validation, technical file management, statistical process control (SPC), auditing, problem solving, coaching and people management Tool skill: MS suites, Minitab, Solid Works, IQMS, SAP, Agile, Trackwise, Master Control, ARIS Modeling, PTC Windchill Language: Fluent in English and Mandarin