Independent Consultant @ Self-employed (August 2021 - September 2022)
Quality Manager @ (January 2021 - August 2021)
Quality Manager @ Oculeve Inc. , now part of Allergan (June 2019 - August 2020)
Staff Quality Engineer @ Spirox, Inc. (acquired by Entellus and Stryker Inc.) (June 2016 - April 2019)
Vivi Lam Education
San Francisco State University
BS Biology (Microbiology, Chemistry)
1999-2005
Vivi Lam Skills
System Requirements
Management Review
Supplier Quality
Corrective Actions
External Audits
Quality Management
Product Development
Medical Devices
ISO 13485
FDA
Design Control
CAPA
Quality System
V&V
Validation
ISO 14971
Regulatory Affairs
GMP
21 CFR Part 11
Biotechnology
Biomedical Engineering
R&D
Change Control
CE marking
Minitab
Design of Experiments
Quality Assurance
FMEA
Catheters
Manufacturing
Quality Control
Quality Auditing
Cross-functional Team Leadership
SOP
Standard Operating Procedure (SOP)
Research and Development (R&D)
U.S. Food and Drug Administration (FDA)
SAN
Standard Operating Procedure Sop
Manufacturing Engineering
Public Speaking
u.s. Food and Drug Administration Fda
Engineering
Cross Functional Team Leadership
Inspection
SQL
Research and Development R&d
Standard Operating Procedure
Research and Development
u.s. Food and Drug Administration
Vivi Lam Summary
Vivi Lam, based in Alameda, CA, US, is currently a Quality Engineering Manager at Endovascular Engineering. Vivi Lam brings experience from previous roles at Self-employed, Alydia Health, Oculeve Inc. , now part of Allergan and Spirox, Inc. (acquired by Entellus and Stryker Inc.). Vivi Lam holds a 1999 - 2005 BS Biology in Microbiology, Chemistry @ San Francisco State University. With a robust skill set that includes System Requirements, Management Review, Supplier Quality, Corrective Actions, External Audits and more. Vivi Lam has 2 emails and 1 mobile phone numbers on RocketReach.
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