Carol Chiu
Portland Or Can Be Relocated,USA
Summary
Dependable professional with track record of success in field, attention to detail and proactive mindset. Flexible in different situations and dynamic conditions. Works great under extreme stress and deadlines. Seeks opportunities to broaden experiences and knowledge of the field for team benefit. Highly-motivated with desire to take on new challenges. Adept at working effectively unsupervised and quickly mastering new skills. Conscientious, hardworking and excels at multitasking in fast-paced environments.
Overview
21
21
years of professional experience
Work History
Chief Manufacturing Officer
LuulaTech Inc
Portland, OR
06.2021 - 06.2022
- Responsible for QMS procedures for product life cycle, including design, manufacturing, customer services, and maintenance.
- Overseeing the product's global regulatory compliance requirements (including liaison with FDA consultants, IEC standards, and risk management, MDD/MDR).
- Product development coordination with the design team and business development.
Technical Specialist & Scheme Manager
BSI Canada
Vancouver, BC
10.2017 - 05.2020
- Responsible for project managing a portfolio of clients to conduct the initial and ongoing maintenance of regulatory certification against EU regulation and MDSAP program.
- Responsible for review of technical files for compliance with the Medical Device Directive and the Medical Device Regulation for initial or continuing assessments (including, but not limited to, risk management reports, technical standard reports, labels, and operational manuals).
- Products range from X-ray equipment, Ultrasonic equipment, Blood Pressure monitor, Glucose meter, audiometers, proton beam therapy, TENS devices, defibrillator, Infusion pumps, retinal cameras, hearing aids, dental devices, HF generators/surgical devices, SaMD, SiMD, collaboration review in regard to Active Implantable devices such as vascular catheters, balloon catheters, etc.
North America Market Analyzer
ANLY Electronics Ltd
Portland, OR
07.2015 - 08.2017
- Responsible for market research for Asia electronic components for North America industrial markets.
- Researching product standards that are required for entering the N America market.
- Interfacing with North American clients and Asian manufacturers.
Senior Expert – Medical Devices
TUV Rheinland Japan Ltd.
Yokohama, Japan
08.2004 - 06.2015
- Responsible for project handling of key clients to ensure satisfaction and repeat business.
- Responsible for evaluating, technical certification, and certification of medical device and in-vitro diagnostic device test reports for IEC 60601 series, IEC 62304 (software), IEC 62366 (usability), and IEC 61010 series.
- Responsible for providing technical review (specifically ISO 14971 risk management, IEC standards test report reviews) in support of medical auditors during QMS / MDD Notified Body audits (MDD expert) and PAL, SFDA (now NNPA) applications.
- Responsible for the training and qualifications of medical device project handlers.
- Qualified as a QMS auditor for ISO 13485.
- Pr
Project Engineer – ITE / Medical Devices
Underwriters Laboratories
Camas, WA
09.2001 - 06.2004
- Responsible for the project handling of ITE products, AV apparatus products (evaluating products per standards including creating test plans, witness testing, report writing)
- Also due to the language ability (Mandarin) acts as project coordinator between American engineers and Chinese clients, laboratories, Chinese subsidiaries.
Education
MBA - Logistic Management
University of Portland
Portland, OR08-2002
Bachelor of Science - Electrical Engineering
University of Portland
Portland, OR06-2001
Skills
- Strong communication skills were
enhanced through my experience working
for a global companies ( UL, TUV Rheinland Japan, BSI Canada) with different culture backgrounds, language, and time zones - Developed multiple priorities management for constantly juggling with multiple clients and projects
- Technical Qualifications include:
Nearly 20 years of experience in
IEC standards (IEC 60601-1
collateral, particulars and
national differences, IEC 62304,
IEC 62366 etc) MDD
Expert for Active Medical Devices
(qualified in Germany), IECEE
Technical Peer Assessor (qualified
by IECEE), Global Technical
Competence Center for Medical
(qualified globally by Notified
Bodies)
Languages
Chinese (Mandarin)
Native/ Bilingual
japanese
Limited
Timeline
Chief Manufacturing Officer
LuulaTech Inc
06.2021 - 06.2022
Technical Specialist & Scheme Manager
BSI Canada
10.2017 - 05.2020
North America Market Analyzer
ANLY Electronics Ltd
07.2015 - 08.2017
Senior Expert – Medical Devices
TUV Rheinland Japan Ltd.
08.2004 - 06.2015
Project Engineer – ITE / Medical Devices
Underwriters Laboratories
09.2001 - 06.2004
MBA - Logistic Management
University of Portland
Bachelor of Science - Electrical Engineering
University of Portland
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