Quality Assurance Engineering
Resume:
TIEN T. LE
Blvd
Ste B # ***
Santa Ana, CA 92704
Telephone: (714)-
Email:
*********@*****.***
POSITION:
SR. QUALITY ENGINEER/MANAGER
Teva Incorporate, Irvine, CA 03/2011-07/2011 (Contract-Quality
Engineering Investigator)
Allergan Incorporated, Irvine, CA 09/1998-01/2011 (Quality Engineering
Professional)
QUALITY RELATED WORK ACHIEVEMENTS:
Ensuring products and assemblies meet specifications and are developed and
manufactured with highest product quality and meet all applicable product
quality, design and manufacturing process requirements.
Providing leadership in areas of process engineering, product quality
assurance and quality engineering to drive continuous process and product
improvements for Class I (low risk), Class IIa (low medium risk), Class IIb
(medium risk), and class III (high risk) implantable devices.
Experiences in providing applicable product and manufacturing process
requirements for class III implantable glaucoma drug delivery system as
well as diabetic glaucoma drug delivery system.
Conducting all engineering activities in compliance with FDA Regulations,
ISO 13485 and other national and international quality and regulatory
requirements and standards.
Be able to investigate root causes and implement corrective and preventive
actions
Familiar with ISO-9000 and other quality related technical standards
Experienced to conduct internal audits and external audits.
Knowledge of Quality, Lean and SPC, Six sigma, Continuous Improvement
Engineering, Root Cause Analysis principles, 8D, FMEA, MDD, ISO 13485
Leading the product quality assurance and quality engineering aspects of
activities to drive strong engineering and technical knowledge and
application.
Establishing quality assurance, engineering programs, and initiatives to
ensure products and assemblies are developed and manufactured in accord
with applicable requirements.
Working closely with Manufacturing/Operations, R&D and other departments to
ensure highest quality products and processes are developed and deployed
and are engineering sound. This includes product design testing, process
testing, characterization, qualification, validation, risk analysis/FMEA,
etc.
Demonstrating solid understanding of internal and applicable external
policies, procedures and standards.
Supervising and coordinating specialized contract personnel and outside
vendors in the performance of contract validation services.
Representing company in contacts with inspectors from FDA and ISO.
Ability to apply quality engineering to specification and validation of
pharmaceutical/ medical manufacturing facilities and systems. Writing and
implementing IQ (Installation Qualification)/OQ(Operational
Qualification)/PQ (Performance Qualification) for pharmaceutical/medical
device systems and manufacturing facilities.
Conducting complaint investigations and providing corrective and preventive
actions based on sound engineering analysis and review. Providing effective
solutions that will drive continuous and measurable improvements.
Developing systems for the identification, analysis, correction, and
prevention of quality issues.
Managing returned product analysis and failure investigation activities for
manufactured products.
PC skills: Applications software supporting statistical data analysis, word
processing, project management, visio, CAD, SharePoint, QMS, Trackwise
Capacity to function in an interactive team environment.
Excellent team player with strong customer orientation and ability to work
in multinational and multi-culture environment
Excellent written and verbal communication skills
Ability to conduct routine and special studies with minimum supervision.
Excellent technical report writing including generating and approving
validation protocol and report.
Good project management skills
Strong problem solving skills
Good Presentation skills
Ability to work in clean room and laboratory
QUALITY ENGINEERING RELATED EDUCATIONS:
Mississippi State University, Mississippi
Master of Engineering, Industrial and Quality System
Graduation date: 2012
Cal State University Long Beach, Long Beach
Bachelor of Science, Engineering Technology
Graduation date: 2002
REFERENCES:
References available upon request.
Contact this candidate