Quality Assurance Manager

Garth M. Nobis 408-***-****, *******@*****.***) page 3

Garth M. Nobis

San Jose, CA

408-***-**** *******@*****.***

Complete resume available

Quality Assurance and Regulatory Affairs Executive experienced in Medical Device quality

systems, regulatory submissions, and quality management for development and production life cycle

phases of companies having innovative products. Over 15 years Vice President or Director level

leadership in early stage, pre-IPO and Fortune 100 companies.

Leadership strengths include:

Company and product strategy Hands on, “can do” implementation

Planning and project management Internal and external communication

Business growth management

Team building, employee development

Quality/Regulatory/technology strengths include:

FDA QSR/GMP quality systems Japanese regulatory/business

Class II and III products Excellent writing skills

ISO 13485 quality system registrations Operations/continuous improvement/SPC

FDA, State, Notified Body inspections Electronics/electro-mechanical/software

510(k), IDE and PMA submissions Radiation capital equipment

Design control, risk management Cardiac stents and catheters

CE mark submissions (Europe) Ophthalmic instrumentation

MDR and recalls Diagnostic instruments/reagents

Major accomplishments include:

Established and revised quality systems Strengthened Design Control, Software QA,

Achieved (4) 13485/9001 registrations and IEC Standards performance

Achieved (10) 510(k) clearances Established Quality/Regulatory platform in a

Hosted >20 FDA and State inspections small company for CE, clinicals

Hosted numerous Notified Body audits Established productive teams

Achieved CE, Japan, and Canadian Supported significant aggressive stent

marketing approvals; submitted IDE business growth

Executive team in 500% growth company

Participated in successful IPO

PROFESSIONAL EXPERIENCE

Vice President, Regulatory Affairs and Quality Assurance

ORAYA THERAPEUTICS, INC. Newark, CA (Ophthalmic/radiation device, startup) 2007–2009

Vice President, Quality Assurance and Regulatory Affairs

ACCURAY, INC. Sunnyvale, CA (CyberKnife System for radiosurgery) 2002–2007

Director, Regulatory Compliance, Vascular Intervention Group

GUIDANT CORPORATION, Santa Clara, CA 1997--2002

Director, Quality Management

BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS, San Jose, CA 1992–1997

Director, Quality, ITT ELECTRONIC COMPONENTS (CANNON), Santa Ana, CA

Corporate Manager, Supplier Quality Improvement; Manager, Quality Improvement, BECKMAN

INSTRUMENTS, INC., Fullerton, CA

Quality Assurance Manager, EMERSON ELECTRIC/BECKMAN INDUSTRIAL, Fullerton, CA

Quality Manager/Sr. Quality Engineer, Engine Electronics, MOTOROLA, Seguin, TX

Various positions, GENERAL MOTORS CORPORATION, Dayton, OH and Warren, MI

Garth M. Nobis 408-***-****, *******@*****.***) page 3

EDUCATION

MBA, University of Dayton, Dayton, Ohio

BIE (Industrial Engineering), General Motors Institute (Kettering University), Flint, Michigan

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