Resumes
Resumes
Senior Quality Engineer
View pageLocation:
South San Francisco, CA
Industry:
Biotechnology
Work:
Irwin & Associates, Inc.
Engineering Consultant
Genentech Jul 2016 - May 2019
Senior Site Manager, Devices
Genentech Oct 2011 - Jun 2016
Senior Site Manager, Combination Products, External Manufacturing
Cirtec Medical Jan 2008 - Oct 2011
Senior Manufacturing Engineer
Alacrity Engineering Jan 2005 - Oct 2008
Senior Mechanical Engineer
Engineering Consultant
Genentech Jul 2016 - May 2019
Senior Site Manager, Devices
Genentech Oct 2011 - Jun 2016
Senior Site Manager, Combination Products, External Manufacturing
Cirtec Medical Jan 2008 - Oct 2011
Senior Manufacturing Engineer
Alacrity Engineering Jan 2005 - Oct 2008
Senior Mechanical Engineer
Education:
Stanford University
Bachelors, Bachelor of Science, Mechanical Engineering San Francisco State University
Master of Business Administration, Masters
Bachelors, Bachelor of Science, Mechanical Engineering San Francisco State University
Master of Business Administration, Masters
Skills:
Manufacturing
Medical Devices
Fda
Engineering
Cross Functional Team Leadership
Design Control
Validation
Quality System
Iso 13485
Biomedical Engineering
R&D
Design of Experiments
Capa
Product Development
Process Simulation
Root Cause Analysis
Quality Management
Program Management
Fmea
V&V
Injection Molding
Gmp
Manufacturing Engineering
Start Ups
Product Launch
Process Improvement
Mechanical Engineering
Spc
Lean Manufacturing
U.s. Food and Drug Administration
Six Sigma
Iso
Regulatory Affairs
Technology Transfer
Solidworks
Minitab
Jmp
Clinical Trials
Supply Chain Management
Dmaic
Aseptic Processing
Clinical Research
Supply Chain
Change Control
Regulatory Submissions
Quality Assurance
Cgmp Practices
21 Cfr
Risk Management
Process Validation
Medical Devices
Fda
Engineering
Cross Functional Team Leadership
Design Control
Validation
Quality System
Iso 13485
Biomedical Engineering
R&D
Design of Experiments
Capa
Product Development
Process Simulation
Root Cause Analysis
Quality Management
Program Management
Fmea
V&V
Injection Molding
Gmp
Manufacturing Engineering
Start Ups
Product Launch
Process Improvement
Mechanical Engineering
Spc
Lean Manufacturing
U.s. Food and Drug Administration
Six Sigma
Iso
Regulatory Affairs
Technology Transfer
Solidworks
Minitab
Jmp
Clinical Trials
Supply Chain Management
Dmaic
Aseptic Processing
Clinical Research
Supply Chain
Change Control
Regulatory Submissions
Quality Assurance
Cgmp Practices
21 Cfr
Risk Management
Process Validation
Certifications:
Certified Quality Engineer (Cqe)