Medical Device Quality Assurance

Name: Frank Margherita

Address: ** ****** ******

City: Wakefield

State: MA

Zip/Postal Code: 01880

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E-mail: *****@***.***

Primary Phone: 781-***-****

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Copyright c 1997- Lee Hecht Harrison, Inc.

FRANK MARGHERITA

13 Summer Street

Wakefield, MA. 01880 *****@***.*** Home: 781-***-****

Mobile: 617-***-****

Summary

Proven leadership and management in quality assurance and related operations for high

technology products and services. Using Quality as an enabler to achieve competitive

advantage with respect to business strategies and to sustain corporate culture. Diverse

design and manufacturing environments such as Medical Device, Defense, Electronic Design

Automation and Computer Hardware.

Areas of Expertise

ISO9001 & FDA 21 CFR820

Software Test/Management

HW/SW Design Assurance

Metrics & Analysis

Process Improvement

Lean & Six Sigma management Medical Device/Informatics

Reliability/Maintainability

Accomplishment Highlights

Metrics-driven culture shift in global Software organization enabling higher product

quality

Innovative test automation, methodologies and test coverage for improved defect detection

Adaptive FDA GMP system deployment for rapid-growth private equity medical device

Successful ISO 9001 deployment & certification for medium-size OEM

Professional Experience

CADENCE DESIGN SYSTEMS, Chelmsford, MA 20002010Senior Manager, Software Quality

Led team (12) of cross-geographic software test engineers validating digital and mixed

signal logic design & verification software, used by semiconductor and electronics firms

engineering.

Increased initial quality of major releases by achieving zero critical defects through

metrics-driven quality program; raised pre-release defect resolution rate from 70% to 85%

within 2 years; enabled faster customer adoption via reduced qualification effort

Achieved a 70% reduction in customer defect responsiveness via push-model defect

management workflow, (average 30 days to below 10 days); enabled Cadence to meet or exceed

quality of service contracts with premier partners, and verification unit maintained

highest customer satisfaction rating

Introduced software Root Cause Analysis capability; change agent for successful

deployment using pilots. Resulted in improved identification of User Interface reliability

defects, higher stability, and lower customer defects trending year-year; successfully

adopted into enterprise quality system

Deployed auto-generated customer document set (problem work-arounds ) using lean

techniques. Adopted by 50% of business groups, added to enterprise QA system. Resulted in

uniform customer facing documents

Co-authored technical papers, accepted at Cadence Technical Conference: GUI Automation

Techniques ; TCL-Based Exhaustive Testing . Deployed similar techniques resulting in 30%

higher functional test coverage with near-zero impact to test infrastructure and resources

Accountable for software quality in partnership with India, Israel site test teams.

Functions included Staffing/talent management, capital/asset budgeting, test strategy,

metrics/analysis (internal/customer)

Increased customer-centric test capabilities by leveraging customer facing groups expert-

expert business model. Increase test team visibility to customer environments

Talent management successes include 100% new hire retention, dynamic teaming on global

scale

eMed TECHNOLOGIES, Lexington, MA 19962000Quality Assurance Manager

Medical informatics private equity-Tele-Radiology, Mini-PACS (Picture Archiving

Communication system). Successful expanded QA roles with rapid company growth (10

employees to 200)

Managed SW & Systems Test (5), Documentation Control, test laboratory (harness,

infrastructure); performed automated & manual tests (UNIX, WIN), customer-site/field

service support.

Developed and managed FDA GMP Quality Assurance program; performed GMP audits, training,

deployed Corrective And Preventive Action process. Achieved successful FDA facility

inspections

Improved FDA failure reporting compliance via new complaint flag process within Call

Center ERP; resulted in earlier complaint notification, timely customer resolution

ANALOGIC CORPORATION, Peabody, MA 19901996Quality Assurance Engineer

- Computer Design & Applications, Medical Divisions

Supervised supply chain QA (supplier, material inspection, manufacturing and final QA)

Project lead for Computer Division initial ISO9001 certification; achieved approval on

schedule

Maintained medical device complaint handling to FDA compliance; Safety/Regulatory testing

(UL, CSA)

Deployed Zero Defects, Total Quality Management, Just in Time quality methods,

supplier quality programs. Received customer quality award for 100% first-pass test yield

milestone

ADDITIONAL EXPERIENCE

WANG LABORATORIES, Lowell, MA 19871990Reliability and Maintainability Engineer

Developed database-driven solutions for Life Cycle Cost & Service Agreement Profitability

Models (using reliability and life cycle algorithms); resulted in optimized profit margins

& inventory management

TEXTRON DEFENSE SYSTEMS, Wilmington, MA 19851987Reliability Engineer

Performed Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), component

stress testing, Reliability Prediction via MIL-217 standard; Manufacturing Failure Review

Board (QA); generated systems reliability reports to Air Force Ballistic Missile Office

(contract compliance)

INDUSTRY TRAINING, CERTIFICATION

Six Sigma- Management Champions and Lean Systems(SkillSoft e-courses)

Certified Quality Manager (SkillSoft e-course)

IT Infrastructure Library - ITIL V.3 Foundation (SkillSoft e-course)

Education

M.B.A

., Operations (candidate), Northeastern University, Boston, MA (Expected 2012)

B.S

., Electrical Engineering, Northeastern University, Boston, MA (1986)

Volunteerism

Friends of Lake Quannapowitt, Wakefield, MA

Treasurer, Board of Directors (2008- Present)

Frank Margherita Page

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