Portia

About Portia

18 years of experience in Quality/Regulatory Functions in medical device/pharmaceutical industries• Experience in the development and manufacturing of medical device including disposibles/electro-mechanical and diagnostics products, sterile solution and sets, biologics, and nutritional products• CFR820, 210, 211, 58/cGMP/ISO 13485, ISO14791, ISO17025/ICH Q8-10/EN46001, CMDCAS, MDD and JPAL Compliance, IVDD98/79/EC• Total Supplier/Supply Management• Cost of Quality/Lean• Design Control/Purchasing Controls/CAPA/Risk Management/Project Management/SPC/PDCA• Regulatory body interaction including Inspection Support• Quality Systems development and deployment• Experience in cross-functional team development and implementation strategies• Familiar with sterilization processes including aseptic fill, moist heat, EO, Gamma and e-beam.• MS in Chemical Engineering• ASQ CQE CQA • Culturally diversified—proficient in understanding and overcoming different cultural and language obstaclesSpecialties: Purchasing and Supplier Management, Supplier Quality, Audits, Training, CAPA, Design Control in matrix organizationLanguage: English, Chinese

Experience

1. Sr Director, Quality Management

   BD

   Oct 2022 — Present · US

   Responsible for Pre & Post Market Product Quality, QMS, Compliance, M&A for the fast growing BD Biosciences business unit

Education

• Brigham Young University

  Master of Science - MS and PhD Course Work, Chemical Engineering

  1991 — 1994

Skills

• Spc
• Design Controls
• Supplier Quality
• Auditing
• Project Management
• Risk Management
• Purchasing Management
• Capa