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Quality Assurance Medical Device

Location:
Byron, CA
Posted:
November 25, 2012

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Resume:

NAME: Ellsworth, Ron

ADDRESS: **** ******* *****

ADDRESS2:

CITY: Discovery Bay

STATE: CA

ZIP: 94514-1404

CANDIDATE ID: 2304163

US CITIZENSHIP: US

Citizen

EDUCATION: Bachelor Degree

EXPERIENCE: 14

WILL RELOCATE: Yes - All United States

JOB WANTED: Any

RATE NEEDED: $100,000 to $110,000

TELEPHONE: 925-***-****

EMAIL: abpr62@r.postjobfree.com

HOMEPAGE:

COMMENTS: Ron Ellsworth

Product Assurance-Quality Assurance, Reliability, Regulatory

925-***-****

Rons background is in Development and Manufacturing Quality and Reliability, as well as computer hard drives at Toshiba. Hands on Quality Program leadership experience in MIL Spec, Space Reliability, and commercial environments give him a unique insight into Quality Management practices.

He has more than 15 years hands on experience directing, developing, and overseeing Quality and Reliability Operations, doing and managing Regulatory, Reliability Engineering, Component Engineering, ORT, FCC testing and registration, Inspection, Supply Base Quality Assurance, and Quality Engineering.

He has led the development and

HOTTEST SKILLS: Director/Manager-QA/ReliabilityRegulatory

REVISION: 18-DEC-01

YOE: 14

RESUME:

RONALD D. ELLSWORTH

925-***-****

(home)

Highlights of Experience

Knowledge, Experience, and Ability-Doing, Managing, and Directing Quality,

Regulatory, and Reliability. Hands-on accomplishments in difficult high

visibility Reliability and Quality posts in technology driven R&D and

manufacturing.

Industry expertise embraces Wafer Fab, GaAs and Si Hybrids, Micro-Machining,

Microwave, Ultra-Sonics, RF, Sensors, Oscillators, Digital Radio, Medical

Devices, Telecommunications, Frequency Control, Power, Crystals, Space

(satellite) Reliability, Automotive, Hydraulics, Machine Shop.

Talents and Abilities Include: Bandwidth-The Ability To Do Every Job And To

Achieve The Difficult Objective, Planning, Implementation, and Strengthening of

QSR/ISO-QS9001/ ISO 13485-EN46001/MIL Based Quality Systems, Quality Planning,

FDA, FCC, Problem Resolution, Medical Devices, Regulatory, Risk Analysis,

FMECA, Tech Files, Essential Requirements, Vigilance, Instruments, UL, CE Mark,

CSA, Ongoing Reliability Monitors, Design Control, SPC, Six Sigma, CQE, JIT,

Semiconductor, GaAs, Sensors, R&D; CCB, MRB, CAR; SCAR; DOE, 8D, Q-1; Taguchi;

MPE; All-around Customer and Supplier Dialogue, Reports, Presentations;

Training; Procedures, Work Instructions, Malcolm Baldrige National Quality

Award, TQM, Regulatory Jungle Trail Blazer, a Team Worker That Will Seek

Consensus, Assembling and Developing Strong Organizations.

Ability to analyze complex problems and apply fitting actions to their

resolution; multi-task, applying cross-functional team leadership skills,

handle multiple projects; lead innovatively-taking responsibility, achieving

goals, producing desired results; lead by example, applying my rock-solid

background in QA/Rel/RA operations; coach skillfully, drawing on extensive

technical and managerial skills. Resourceful and inventive.

Positions have included Quality, Regulatory, and Reliability Management, Plant

Management, Product Engineering, Reliability Engineering, Process Quality

Engineering, R&D, and Purchasing. Was Quality Assurance and Reliability

consultant to medical device and disk drive industries, documenting various

protocols for Design Validation/ Verification and Manufacturing and integrated

GMP/ISO provisos into robust high volume production.

Motivational skills: (HIT) Honesty, Integrity, Teamwork - (C3) Capability,

Contribution, Character.

Experience

9/9/99

PresentDirector-Corporate (Worldwide) Quality Assurance and

Reliability SaRonix, Menlo Park

Design and manufacture frequency control products for sale to Lucent, 3COM,

Cisco Systems, Nortel, Alcatel, IBM, Sun Microsystems, PC manufacturers,

distribution.

Downsized due to sales implosion.

Report to President/CEO with 6 direct reports and 85 indirect reports

worldwide. 150 Corporate HQ employees

Accountable for the achievement of worldwide product and process Quality and

Reliability, creating and driving Quality Initiatives, Quality and Reliability

policy, and procedures for product improvements in seven USA, European, and

Asian ISO 9000 certified facilities, failure analysis and continuous

improvement.

Manage all aspects of corporate Quality and Reliability Programs.

Far ranging customer and supplier dialogue and associated program Quality and

Reliability Planning.

Established detailed Quality Planning and Ongoing Reliability Monitors in all

facilities.

Established quality communications guidelines, improving response to global

customer issues.

Employed quality disciplines that resulted in 25% improved DPM and reliability

at all sites.

Developed QS90000 program.

Implemented 8D analysis and Corrective Action process in European facilities.

Initiated Maverick Product Elimination for hybrid RF electronics products.

(Stepping stone to 6 Sigma)

Developed Cost of Quality program.

Negotiated supplier settlements for losses incurred owing to raw material

defects (ICs, substrates).

Supplier survey scores improved 5-15% in all facilities.

Received Zero Defect and Supplier of Year awards.

3/94

- 9/99Manager of Quality Assurance and Regulatory Orthopedic

Systems, Union City

Design and manufacture Medical Devices and accessories for sale to

distribution, hospitals, HMOs, clinics.

Report to Vice President of R&D with 5 direct reports, (165 employees).

Hands-on proactive direction of Quality System Regulation and ISO 13485-

EN46001 implementation/ certification.

Implemented European Directives and International Standards for CE

Marking of Medical Devices and instruments, including Tech Files, Risk Analysis

(FMECA), Vigilance, Essential Requirements, etc.

Managed medical device design, testing and listing to latest UL, CSA,

and international standards.

Implement and Direct equipment QA, RA, MDR, MDD, Reliability, Listing,

and Regulatory provisos.

Integrated ISO/QSR/EN/MDD provisos into Product Development and

Manufacturing Operations, sustaining robust creation and manufacture of Medical

Devices, equipment and accessory products.

Proceduralized 510K process.

Directed all inspection and dispositioning activity.

10/92

- 11/93Quality and Reliability Operations ManagerToshiba America

Hard Disk Drives, San Jose

Design and manufacture of SCSI disk drives for servers and PCs.

Plant closure. Toshiba America Information Systems Hard Disk Drive

group disbanded

Report to Vice President of Operations with 13 direct reports, (180

employees).

Established Plant Quality and Reliability Engineering and led quality

improvement teams.

Accomplished cost efficient production reliability tests and monitors

(ORM).

Developed Sequential Probability Ratio Tests (SPRT) that:

exposed product weaknesses and afforded direction for improved product

reliability.

precipitated more than 25 incremental product quality improvements.

contributed to lowered prediction of warranty liability, saving upwards of $2

mm in probable warranty cost.

Designed and presented training classes in supplier QA, statistics,

inspection, test, auditing.

Implemented in-line Sequential Sampling plan with Line Stop provision.

Delivered firmware control procedures, ISO quality system plans, audit

plans.

Collected data and published metrics for quality and reliability

activity and results.

Contributed to planned product improvement activities through stand up

meetings and brainstorming.

8/88

- 11/91Director-Quality Assurance NovaSensor, Fremont

Design and manufacture of Micro-Machined sensors-transducers and Medical

Devices for sale to OEMs.

Report to President/CEO/COO with 6 direct reports, (140 employees).

Conducted SPC training for Assembly and Semiconductor Process Engineers.

Developed, directed, conducted reliability procedures, failure and reliability

analyses.

Implementation of Statistical Process Control system, reducing scrap and rework

costs while improving quality.

Achieved TQM framework incorporating GMP, ISO 9000, Q1 (QS 9000).

Created and implemented design control, document control, problem management,

and CI strategies.

Developed Quality Plans and manufacturing validation protocols.

Directed all inspection and dispositioning activity.

6/84

- 8/88Manager of Product Assurance and Reliability Avantek

Semiconductor Group, Santa Clara

Develop and manufacture GaAs and Si semiconductors, ICs, and hybrid assemblies

for sale to sister divisions, defense contractors, communications and

intelligence satellite interests, as well as commercial users.

Report to VP of Operations, Semiconductor Group. Staff of 32, with 5 direct

reports, (200 employees).

Directed QA and Reliability programs, conducted reliability test procedures,

ORM, failure and reliability analyses for three Bay Area sites and Malaysia,

directed Document Control for all sites.

Conducted SPC training for GaAs and Si wafer Process Engineers.

Supported sister divisions with technical presentations to their customers

(Naval Weapons Center, etc.)

Conducted quarterly State of Reliability presentations.

Active role in design input for new wafer fab facility.

Led quality improvement teams in Si and GaAs semiconductor product lines.

Slashed defects to PPM, reducing product DPMs >75%.

Established TQC baseline.

Developed exceptionally proficient QA/Reliability organization, dubbed Center

of Excellence.

Highlights From

Education and Training

BS

- Business Administration, San Jose State University San Jose, CA

Four-Week AMA Management Course, AMA San Francisco, Dallas

Jurans Management of Quality Control (trained by Dr. Juran), AMA

Chicago, IL

ISO 9001 Lead Auditor, 1 week seminar Silicon Valley

Solid State Design and Theory, San Jose City College Silicon Valley

Microwave and Theory. San Jose City College Silicon Valley

Project Management, seminars Silicon Valley

Reliability Engineering, DeAnza College and ASQ Silicon Valley

Deming, ASQ Silicon Valley

ISO 13485-EN 46001, TUV Rheinland Silicon Valley

MBNQA, ASQ Quality Congress San Francisco

TQM, ASQ Silicon Valley

SPC, ASQ Silicon Valley

DOE, Dupont, ASQ Ohio, Silicon Valley

FCC Part 68, George Washington University Wash. DC

Quality System Regulation, workshop Silicon Valley

EU IVD; Medical Device; and Machinery Directives, TUV Rheinland Silicon

Valley

Quality Function Deployment, seminar Detroit, MI

Ford Preferred Supplier Program, Eastern MI University Michigan

Taught electronics for 3 years, USAF Denver, CO

Certifications

Certified Quality Engineer (ASQ)



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