Quality Assurance Engineer

*********@*****.*** TODD SCRUGGS 925-***-****

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SUMMARY OF QUALIFICATIONS

. Principal SQA Engineer-Software Engineer with broad-based experience in

all facets of product development in the Medical Device industry.

Recognized for organization, attention to detail and commitment to

excellence. Consistently led product development teams from conception

through implementation, verification, validation and maintenance

delivering of successful products to the market to ensure products are

developed and introduced into Manufacturing in full compliance with the

FDA CFR 21, ISO 13485, ISO 14971, and CE regulations. Responsible for

creating, reviewing and executing IQ OQ PQ procedures. Experienced in

defining policies and procedures, conducting audits, and leading software

teams. Strengths in firmware development, project management, test tools,

V&V and IQ, OQ, PQ. Participated in CAPA teams in reviewing and

resolving open CAPAs. A team player with strong technical and

communication skills.

TECHNICAL BACKGROUND

Technical: ASQ Sr. CSQE, ISO 9000 Certified Auditor, 21 CFR Part 820 QSR,

ISO 9001, ISO 14971, ISO 13485, IQ OQ PQ, embedded systems design

and development, automated test tools, risk assessment,

verification and validation testing, FDA submissions, device

drivers, PVCS Version Manager, PVCS Tracker, IBM Rational

RequisitePro, DOORS, NI TestStand and NI LabVIEW.

Languages: C++, C, MS Visual Studio, UNIX C-Shell, NI LabVIEW, Various

scripting languages.

Operating Systems: Windows XP, Windows NT, Windows 95, Windows 3.1,

UNIX, Ubuntu LINUX

PROFESSIONAL EXPERIENCE

LidoBay Quality Solutions, Inc. (LBQS) 2008 to Present

Owner

Providing solutions for Medical Device companies needing expert support in

product development, verification and validation. Forming LBQS Corporation

and managing workload to create a profitable company. Negotiating

consulting contracts for LBQS Corporation. Managing all financial

responsibilities for LBQS Corporation.

Boston Scientific, San Jose, CA 2008 to 2010

Multinational Manufacturer of medical devices and supplies, pharmaceuticals

and retail products.

Principal Biomedical Software Engineer - Consultant

Participated in product development as a systems engineer to guide in the

development of system use cases, all product requirements and V&V test

protocols.

Reviewed all requirement traceability from top to bottom of system for

accuracy and effectiveness.

Created and executed software tool validation protocols to allow use of new

software tools for requirements management.

Directed and guided offshore development team in creating of requirements

and V&V protocols.

Maintained SQL database for requirements management tool.

Responsible for ensuring all requirements are traced from Use Case to V&V.

New Frontiers Software, Livermore, CA 2009 to 2010

Multinational Manufacturer of medical devices and supplies, pharmaceuticals

and retail products.

Principal - Medical Device Software Validation Engineer - Consultant

Wrote software validation test procedures. Created and executed automated

software validation test scripts according test protocols and requirements.

Responsible for conducting software code review meetings.

Arbor Vita Corporation, Sunnyvale, CA 2008

Principal Biomedical Software Engineer - Consultant

Created and executed system validation protocols for a non-invasive rapid

diagnostic device for the detection of the avian influenza H5N1 virus in

humans.

Halt Medical Systems, Brentwood, CA 2008

Principal Biomedical Software Engineer - Consultant

Directed the validation efforts of a new device used to treat uterine

fibroids using RF ablation technology.

Wrote the validation summary report submitted as part of FDA submission for

device approval.

Designed, developed and executed system validation protocols for RF device.

Provided GAP analysis for development environment and engineering process

in order to met FDA guidelines.

Co-lead Risk Management process to create the system risk analysis and

Process FMEA as part of FDA submission..

Covidien (Tyco Healthcare, Mallinckrodt, Nellcor Puritan Bennett),

Pleasanton, CA 1994 to 2008

Multinational Manufacturer of medical devices and supplies, pharmaceuticals

and retail products.

Senior Software Engineer 2007 to 2008

Designed, developed and tested software for enhancements to existing

medical device products. Reviewed and approved product and software

requirements. Oversaw and contributed to development of an automated

software validation test platform.

. Created software development plan for a new embedded controller project.

. Developed and implemented software for an automated test system.

. Ported NT based automated test system to XP based test system.

. Trained and mentored new employees for new corporate R&D Headquarters.

. Participated in CAPA team in reviewing and resolving open CAPAs.

Senior SQE 2000 to 2007

Managed and provided software quality leadership to the R&D S/W development

process. Was a mentor for new R&D engineers and junior engineers. Oversaw

and provided direction for adherence to ISO 14971, Risk Management

Controls. This includes working closely with Research & Development to

create and maintain a specific hazard analysis and risk analysis for each

product

. Developed new company software tools using Microsoft Visual Studio.

. Developed and maintained software validation test plans and protocols for

an automated test system.

. Approval of IQ OQ PQ documentation.

. Participated in CAPA team in reviewing and resolving open CAPAs.

. Directed development of manufacturing software.

. Developed best practices for quality assurance models for product

development. Provided leadership to the Respiratory Group. This led to

receiving a Company Leadership Award.

. Integrated new tools into engineering teams' work process which

facilitated adherence to ISO 13485 guidelines. This resulted in

receiving a Stellar Achievement Award.

. Developed quality assurance plans for embedded controller projects.

. Planned and conducted internal audits which ensured that R&D was meeting

company design control requirements. This resulted in on going re-

certification of ISO13485:2003, EC-Certification of Full Quality

Assurance System and EC-Certification of Production Quality Assurance

System.

. Provided training, support and installation for IBM Rational Requisite

Pro requirements tracing tool.

Senior Software Quality Assurance Engineer 1999 to 2000

Provided SQA support for the S/W development process which ensured the

development teams were following the company design controls to meet

requirements for FDA approval and CE marking.

. Developed and maintained software validation test plans and procedures.

. Maintained and reviewed tracing of product requirements through

development, design, verification and validation to meet the product

development QSRs and elimination of software defects before product

release.

. Verified that all system hazards were mitigated and tested.

. Planned and conducted internal audits on a monthly basis meeting the site

design control requirements.

. Participated in CAPA team in reviewing and resolving open CAPAs.

Software Quality Assurance Engineer 1997 to 1999

Developed and maintained software validation test plans and procedures.

Managed and provided SQA support to the S/W development process following

ISO 9001 guidelines. Conducted internal audits.

. Led the software QA process for development on embedded controller

projects.

. Developed software validation test plans and procedures. This resulted

in a product that had no software defects being found after the product

shipped that required a software update.

. Wrote and maintained software quality assurance test plan, test

procedures and test scripts.

. Released validated software to manufacturing along with accompanying

documentation.

. Planed and conducted internal audits for following ISO 9001 guidelines.

Xerox Engineering Systems, San Jose, CA 1984 to 1994

Designer and manufacturer of printers and wide format engineering plotters.

Project Leader / Senior Software Engineer 1989 to 1994

Designed, implemented and supported firmware in C and assembly language for

graphics controllers embedded in laser printers and wide format

electrostatic plotters for the CAD and graphics markets.

. Functioned as the SW project lead for producing software for rapid

adoption into specialized micro-controller based architectures. -

Resulted in the first engineering A/B sized laser plotter on the market

supporting Adobe Postscript, PCL and pen plotter emulation.

. Was the technical interface between XES and Adobe Systems Inc. for co-

development of Postscript interpreters in XES products.

Software Engineer 1984 to 1989

Designed and supported SW for embedded controllers in the graphics printer

and plotter markets

. Functioned as the technical interface between engineering and tech

support that enhanced customer satisfaction and reduced customer

downtime. Resulted in receiving Outstanding Service Award.

. Managed development environment for embedded controller projects,

resulting in shorter product development time.

. Designed and implemented software for manufacturing to conduct automated

testing of embedded controller boards. This simplified the manufacturing

process and reduced manufacturing costs approximately 15%.

. Created and presented product training to manufacturing personnel.

EDUCATION

BS, Computer Science, California State University, Chico, CA

Ongoing Education

Over 800 hours in company sponsored training related to Medical Device

product development and Quality Assurance standards for the medical device

industry.

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