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MAYA CHENG
Mobile: (585) 377-9876 / Home:
(585) 421-1230 / Email Address: maya@hotmail.com
PROFESSIONAL SUMMARY
Accomplished SOFTWARE
QUALITY ASSURANCE & VALIDATION ENGINEER/PROJECT MANAGER with EE background
and two (2) U.S. patents, has over 25 years engineering experience for medical
devices, rail cars, high speed document imaging systems, and software solutions
industries. Diverse roles in computer systems/software verification and validation,
software quality assurance, regulatory compliance, supplier interface, workflow
management tools, real-time embedded and UI software design, localization,
software process improvement, project and product program management to meet a
broad range of global organizational and business needs. A proactive and solutions-focused
performer who routinely sought out to manage project meeting quality, schedule,
and budget commitments. Recent credits include six years of SQA and compliance consulting
involving the development and validation of enterprise quality system software,
medical device software, and automated manufacturing systems. A cumulative
reputation for performance excellence, leadership, and results.
Specialties:
•
21 CFR Part 11, 820, 210, 211; ISO 13485, 14971; IEC
62304; GAMP, IEEE, SEI-CMM, and ITIL
•
Quality System, SOP, Computer System/Software Validation
(IQOQPQ), Change Management
•
Design Control, Traceability Analysis, Software
V&V, DHF, Validation Documentation
•
Software Development Life Cycle, Product and Process
Development, Hazard and Risk Analysis
•
Project Management, Requirement Management, Test
Management, Supplier Management
• Real-time embedded software, RTOS, graphical user
interface, localization
• SDLC management tools (Integrity, Rational,
TFS),
embedded control systems, electro-mechanical
systems
Software Tools/Application:
MetricStream, SAP, automated contact lens &
intraocular lens (IOL) manufacturing lines, purified water system (PLC/OMI),
vision inspection systems (In-house and Cognex), manufacturing execution system
(MES), CNC minifile generator, Blue Mountain Calibration Manager, pipette
calibration, LabVantage (LIMS), ComplianceWire (LMS), Liquent InSight for eCTD,
Phase Forward electronic data capture (EDC) and Clintrial, Documentum, CATSWEB
(Complaint/Non-conformance/CAPA), HP Kintana, PeopleSoft (ERP), PTC Integrity,
Windchill, IBM Rational ClearQuest, ReqPro, ClearCase, DOORS, Team Foundation
Server, Remedy, Alpha Trust, MS Office, Project, Visio, Lotus Notes
CAREER HIGHLIGHTS
BAUSCH & LOMB, Senior Software
Quality Specialist, Rochester, NY
KAWASAKI RAIL CAR, Software Project
Engineer, Yonkers, NY
XEROX CORPORATION, Technical
Specialist/Project Manager, Rochester,
NY
EXPERIENCE
REGLERA, Denver, CO
Quality
Assurance Manager 2011 - 2012
•
Developed SDLC and design control procedures for a
class II diagnostic device product development for Sequenom, San Diego, CA.
•
Trained on PTC Integrity software tools for medical
device/regulated software development. Supported the Integrity solution implementation
for Intermountain Healthcare, Salt Lake City, UT for compliance of MDDS.
•
Supported software FMEA for Medical Modeling, Golden,
CO
•
Supported software validation for Alpha Trust document
signing, and PTC Windchill document and training management systems.
PHILIPS HEALTHCARE, Andover, MA
Compliance
and Computer System Validation Lead @ Validant 2011 – 2011
•
Team lead role for the re-validation of the Supplier
Corrective Action Request System (MetricStream/SAP) as part of the FDA 483
software remediation effort. Plan, prepare and execute independent verification
and validation per Philips SDLC procedures.
BAUSCH & LOMB, Rochester, NY 2005 – 2010
Senior
Software Quality Specialist
•
Led SQA and validation roles to support project
teams engaged in the development and validation of enterprise quality system
software, medical device software for Stellaris (a class II device with
embedded and GUI software), and manufacturing computerized systems in
compliance with the company quality system.
•
Developed or contributed global quality policies and
procedures development, project management plan, validation plan, URS, functional
and design specifications, Part 11 and risk assessments, traceability matrix, test
protocols, test scripts, and test reports.
EXCELLUS
BLUECROSS BLUESHIELD, Rochester, NY 2005 – 2005
Consultant, Rational Software Administrator
Highlights: Performed IBM Rational software installation, configuration,
administration, and training to support 300+ users over twenty projects
KAWASAKI RAIL CAR,
Yonkers,
NY 2003 – 2005
Software Project Engineer
Highlights: Served as the interface between customer and third party suppliers to manage
the delivery of rail car custom software, documentation, and SEI-CMM
certification per contract agreement. Performed software configuration
management and documentation reviews using IEEE standards.
XEROX CORPORATION, Rochester, NY 1984 – 2002
Technical Specialist / Project Manager – Product Program
Management 1999 – 2002 (3 years)
Highlights: Managed an enterprise client-server based print jobs and device
management software product (PrintXChange) release plan and day to day third
level customer support. Supported new product development for a web-based
devices management and remote service solution from concept to launch using
product development process. Developed Market Attack Plan, integrated project
plan, software requirements, validation, support, and launch strategy, and
phase exit reviews documentation. Evaluated, purchased, configured, and administered
Rational ClearQuest and RequisitePro to support defect & change management
and requirement management process.
Technical
Specialist / Project Manager – Product Software Localization 1997 – 1999 (2
years)
Highlights: Managed printer controller GUI software localization process, vendor
interface, software verification and validation, change control to support
international product software releases.
Developed software development project plan and multinational
requirements. Led process improvement
that reduced development time by 30 days.
Senior
Software Engineer / SQA – Product Software Development 1987 – 1997 (10
years)
Highlights: Developed project plan, software requirements and design specifications,
real-time embedded software/firmware, GUI software for large document imaging
systems using C, assembly, real-time languages, RTOS/SUN Solaris, data
acquisition system, in-circuit emulator (ICE), IEEE and SEI-CMM methodology. Leadership
roles for software subsystem team, change control, defect management, co-development
with Japan, and software process improvement.
Electrical
and Software Engineer – Software and Control System Support 1984 – 1987 (3
years)
Highlights: Developed real-time control and data acquisition software applications to
support advanced product concept R&D, and hardware reliability testing. Experience in Power supply, digital &
analog I/O interface, sensors, motors, electro-mechanical hardware, digital
meter, oscilloscope, chart recorder, and data acquisition system.
EDUCATIONAL BACKGROUND
BS in Electrical
Engineering, Polytechnic Institute of New York University in Brooklyn, NY
TRAINING HIGHLIGHTS
ISO 9001: 2000 Lead Auditor on ISO 13485 ISO 13485, CMDR, MDD, JPAL
BSI
Lean Principles / Design for
Six Sigma Medical Device Regulatory
Compliance CFPA
B&L and Xerox Product
Development Process Xerox Management Studies
Program
PTC Integrity for user
and administrator
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