Quality Assurance Medical Device

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Wayne W. Williamson - Medical Device Consultant

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S & W Quality Associates LLC - 1393 Newtown Rd. - Washington, GA 30673 -

706-***-**** - Cell 706-***-**** e-mail ***********@*******.***

Objective:

To provide consulting services to the Medical Device Industry in the areas

of Quality Engineering, Quality Management, and Regulatory Compliance.

Professional Skills:

. QSR & ISO 13485 Auditing

. Supplier Auditing

. Due Diligence Audits

. Design Controls

. CAPA Implementation

. Quality Manual Development

. SOP Development

. Development of Inspection Documents

. Failure Investigations

. Risk Management ISO 14971

. CMDCAS

. 21 CFR 1271 Human Cells, Tissue, and Cellular and Tissue-Based

Products

. Radioactive Seeds for Prostate Cancer

. Complaint Investigation

. Process Validations

. FMEA Development

. FDA Investigation Preparedness

. FDA 483 & Warning Letter Remediation

. Design Reviews

. Management Reviews

. Quality Management

. Microsoft Office Suite

. Statistical Software

Accomplishments

. 30+ years of Medical Device Experience

. Positions held:

* Division V.P Quality Assurance (Management Board Member)

* Director Quality Assurance

* Quality Engineering Manager

* Senior Quality Engineer

* Quality Supervisor

* Production Supervisor

. Developed a Quality Management System compliant to FDA QSR and ISO

13485:2003

. Obtained CMDCAS certification

. Developed a Design Control System

. Developed a Risk Management System compliant to ISO 14971

. Conducted 100+ supplier audits

. Conducted 50+ division level Internal Audits

. Conducted 10+ Due Diligence Audits for potential company acquisitions

. Participated in 10+ FDA Inspections

. Participated in 30+ ISO audits

. Participated in audits on 21 CFR 1271 Tissue Banks

. Responsible for the quality of manufacturing for radioactive seed

implants

. Responded to FDA 483 observations and one Warning Letter

. Participated in approximately 5 recalls.

. Developed CAPA System

. Conducted Failure Investigations

. Conducted Process Validations

. Conducted Process Capability Studies

. Conducted statistical Analysis

. Participated in developing FMEAs

. Participated in Design Reviews

. Prepared vendors for JPAL audits

. Worked with a Japanese partner company

. Traveled to the following countries on business:

* France

* England

* Ireland

* Sweden

* Mexico

* Singapore

* Malaysia

Work History

. S & W Quality Associates LLC Medical Device Consultant

5/2007 to Present

. C. R. Bard, Inc., Urological Division V. P. Quality Assurance

3/2004 to 5/2007

. C. R. Bard, Inc., Urological Division Director Quality

Assurance 12/1995 to 3/2004

. C. R. Bard, Inc., Urological Division Quality Engineering

Manager 8/1991 to 12/1995

. C. R. Bard, Inc., Urological Division Sr. Quality Engineer

1/1991 to 8/1991

. Kendall Healthcare Company Quality Assurance Supervisor

7/1983 to 1/1991

. Kendall Healthcare Company Production Supervisor 9/1980

to 7/1983

Education & Certifications

. BBA in Business Management, Georgia Southern University

. ASQ Certified Quality Engineer

. Certified Lead Assessor

Wayne W. Williamson

S & W Quality Associates LLC

Consulting Projects

C. R. Bard, Inc.

Urological Division

Covington, GA

Contract: May 1, 2007 to June 30, 2007

Work Details:

. Preparation for upcoming 3rd party audit; audited procedures,

protocols, validations, complaints, trending, etc.

. Revised Quality System procedures as necessary in preparation for

audit

. Quality Engineering for a major development project; developed

protocols, statistical analysis, final reports, risk analysis, design

reviews, supplier audits, etc.

Lumenis, Inc.

Santa Clara, CA

Manufacturer of Medical Lasers

Contract: September 5, 2007 to April 30, 2008

Work Details:

. Revise site specific Quality Policies and Procedures to be Global

Policies and Procedures that apply to two (2) domestic sites and one

(1) international site.

. Develop Global Policies and Procedures in compliance to FDA 21 CFR

Part 820 and ISO 13485:2003.

Lumenis, Inc.

Salt Lake City, UT

Manufacturer of Medical Lasers

Contract: July 1, 2008 to October 15, 2008

Work Details:

. Revise site specific Quality Policies and Procedures to be Global

Policies and Procedures that apply to two (2) domestic sites and one

(1) international site.

. Develop Global Policies and Procedures in compliance to FDA 21 CFR

Part 820 and ISO 13485:2003.

C. R. Bard, Inc.

Puerto Rico Manufacturing Operation

Humacao, PR

Contract: November 15, 2008 to February 28, 2009

Work Details:

. Audited 3 years of Device History Records for accuracy and

completeness

. Developed a training program for preparing for FDA & ISO inspections

. Developed a FDA Readiness Manual for FDA Inspections

. Revised the Facility FDA Inspection Procedure

. Reviewed FDA 483 and FDA Warning Letter responses for completeness and

supporting evidence

. Revised 150 IQC inspection documents and submitted Change Requests

through the electronic documentation system

CareFusion

Creedmoor, NC

Contract: October 26, 2009 to April 30, 2010

Work Details:

. Developed Quality Plan Documents for a new Design Control Project

. Developed Risk Management Documents for a new Design Control Project

Ethicon

Somerville, New Jersey

Contract: May 1. 2010 to September 10, 2010

Work Details:

. Suppler Audits per 21 CFR 820 & ISO 13485

Abbott Laboratories, Inc.

Abbott Diabetes Care

Alameda, CA

Contract: September 10, 2010 to May 13, 2011

Work Details: (U.S., England, Ireland)

. CAPA Records review

. CAPA Remediation

. CAPA Mentoring

. CAPA Training

Beckman Coulter

Miami, FL

Contract: June 1, 2011 to June 30, 2013

Work Details:

. CAPA Records review

. CAPA Remediation

. CAPA Mentoring

. Quality Representative on CAPA Review Board

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