Ozzie Aydlett

Principal Consultant

Project Management

Design V & V

Validation Master Plans

Validation Protocol Development

Process Development

Validation Reports &

Documentation IQ's, OQ's, PQ's, and PPQ's

Test Method (Variable & Attribute) Development & Execution

Engineering Design Specifications

Corrective Action and Preventive Action

Statistical Subject Matter Expert

Supply Quality Chain

Risk Management ISO 14971

ISO 13485 - Medical Devices - QMS

Hands on FDA cGMP's, QSR's

& ISO 9000 requirements

Oswald Aydlett

I am writing to express my interest in the Principal Validation consulting

position, which your organization may have at this time. I am a highly

talented and accomplished Principal Engineer consultant with an extensive

background in Process Excellence and Quality set forth in FDA 21 CFR 820 -

Medical Devices and FDA 21 CFR Part 803 Medical Device Reporting & ISO

13485 Medical Devices - QMS. Now I would like to bring my skills and

expertise to work on this project.

Accustomed to fast-paced projects where deadlines are a priority and

handling multiple jobs is the norm, I enjoy a challenge and take pride in

my work. If you're looking for a qualified professional who seeks

challenges then I believe I am the right person for this project. I have

enclosed my resume for your review. A few highlights from the 3 major

projects I was intensely involved in last year at AMS - San Jose

California, Zimmer Orthopedics - Warsaw, IN and Smith & Nephew, Memphis TN

includes:

> Implement Quality Management System & Manage Process Validation

Programs & Training:

o Implement Manage QMS and validation program for the Console and

Fiber Manufacturer in order to ensure regulatory compliance and

current good manufacturing practice.

o Develop Design V & V requirements to include, DIDO, Design

Control Procedures, and Design Transfer requirements

o Qualifications to include XPS Consoles with Moxy 2030 Fiber, HPS

Consoles with 2900 Moxy Fiber

> Risk Management & Calibration:

o Risk Management: Identifying risk hazards according to ISO

14971 & 13485 associated within the client's product lines,

estimating and evaluating potential risks of those hazards.

Mitigating and controlling the risks and to monitor the effects

of the current controls.

o Supply Chain Quality/Calibration: Investigating and facilitating

supplier change notification, review and approval. Investigating

and sustaining the current Calibration Alert process.

> Validation Project Requirements:

o Work with R&D, Operation, and Supply Chain throughout the

validation lifecycle.

o Review product characteristics and requirements with the

assessment of the User Requirements Specification (URS),

Functional Design Specification (FDS) and Traceability Matrix

(RTM) processes.

o Validation test methods were created to test the robustness of

the process.

o CAPA root cause analysis with quality plans

With my 15 years of hands-on experience and practical knowledge of the

Medical Device and Pharmaceutical industries are well suited to the goals

you need for this project. I would like the opportunity to discuss how my

experience and skills can help your organization.

Sincerely,

Oswald Aydlett

Oswald L. Aydlett, II

1536 Kerley Drive #444 (408)

655-9866 cell

San Jose, California 95112

abp2xb@r.postjobfree.com

Objective: Seeking a consultant position as a Principal Consultant, which

my Manufacturing, Validation, Business Optimization, Process Improvement

Techniques, Project Management, Design Technology Transfer, Six Sigma,

Validation, Supply Quality Assurance and Compliance experience and skills

can be effectively utilized.

Summary of Qualifications:

. Team Building - Decisive team leader with extensive experience

developing talent and creating

effective training programs

. Communication - Persuasive communicator with well-developed

presentation and negotiation skills

. Strong leader in process optimization, equipment and process

validation domestically and internationally

. Able to develop productive relationships with colleagues, customers

and staff at all levels

. Lean/Cellular, 5-S, Kaizen, Kanban, and SPC Manufacturing Experience,

Project Planning Experience (Microsoft Project)

. Expert in Minitab Statistical Software (DOE experience): Release

V.15.1.1

. Successful implementation of ISO 9002/ISO14001, ISO 13485

. Familiar with 21 CFR 820, 21 CFR 11, 21 CFR 210 & 211

. Familiar with class II &III Medical Devices, 510K procedures, CAPA, CE

Markings

. Strong leader in the development of training the trainer

. Strong leader in design technology transfer from one facility to

another

. Strong project leader among the medical device industry

. Lead supply chain with supplier to supplier consolidation efforts.

. Strong team member in the development of six sigma methodologies:

DMAIC, DFSS

. Strong coach, mentor, teacher and implementation of EVOP's, Response

Surface Methods, Central Composite Designs, Full and Fractional

Factorial's DOE's.

Consultant Employment Summary

Independent Consultant (March 2008-October 2009, September 2011 thru June

2012, and August 2012 - present) Project Include:

Employment History

August 2012 - Present (Contract)

Principal Consultant / Program Manager - American Medical Systems. San

Jose, California

Develop the validation strategy for the entire organization to include:

processes, test method validation, sterilization validation, and facility

validation. The validation strategy is based on a risk base approach.

Create the entire validation infrastructure for the organization to

include; test method validation, process master validation plans, and

process validation documents (IQ, OQ, and PQ). Two Commercial products:

Consoles and Fibers, electro-mechanical and optics-mechanical

. Program Manager for Remediation/ Continuous Improvement Validation

Program

. Working cross functionally with many teams within the organization:

R&D, Operations. Facilities, Maintenance, Regulatory, Supply Chain

. Provide leadership to cross functional teams with defining clear,

realistic goals; removes barriers to team progress, and facilitate

rapid decision-making

. Generates analyses of timeline, resource, and budget information that

facilitate scenario planning, contingency planning, risk assessment

and management, and decision-making with the continuous improvement

program

. Manage thru Risk Assessment

. Manages and monitors team performance metrics

. Executes Project Logistics hold meeting, discuss actions items and

follow ups

. Develop IQ, OQ, and PQ validation documentation, execute validation

documentation

. Develop Systematic CAPA requirements for DMR, RM, PV, SW, and TMV

. Lead validation continuous improvement project from facilities, R &D,

and processes

. Develop SAT for new installation of HVAC commissioning

. Develop Environmentally Monitoring Validation IQ and PQ protocols for

Class 5 (100), Class 7 (10,000) and Class 8 (100,000) clean rooms.

. RoHs validation of products

. Provide workshops on Minitab 15.2 and 16 with Gage R & R and Power and

Sample Size

. Provide guidance for internal development of procedures to include:

Design Control, Design Transfer for product development team members.

. Provide guidance for incoming inspection, supplier audits, process

improvement

. Support teams on risk management assessment to include DFMECA and

PFMEA

. Develop procedures for Gage R & R, Sample Size determination, Process

Validation, Test Method Validation

September 2011 - June 2012 (Contract)

Senior Quality Engineer - Zimmer Orthopedics Statesville, NC / Warsaw,

Indiana

. Develop validation strategy for packaging heat bar sealers

. Develop process parameters and updated all quality documents and

validation documents

. Work with multi sites with the development of IQ, OQ, and PQ

. Develop manufacturing transfer parameter requirements for packaging

validation Lead Lean Six Sigma initiatives for Zimmer Orthopedics.

. Developed level loading process to improve process efficiency

. Designed and developed supermarket rack to improve process flow

. Decreased process steps by 35% and travel distance by 45%

September 2010 - August 2011

Global Transfer Project Manager - Smith & Nephew, Memphis, Tennessee

. Transferred $14million in products throughout the organization

. Designed and developed global manufacturing transfer policy

. Manage all supplier to supplier consolidation transfer projects

. Led new start-up facilities with numerous functions: site layouts,

equipment selection and qualifications, document creation and release,

validation of new equipment and facility, and training of key

personnel

. Lead several supplier audits, CAPA resolutions

. Reduced supplier base and obtain long term strategic partnership

. Implemented pre-activity and validation techniques with all supplier

(MSA, Gage R & R, IOQ, OQ, and PQ)

October 2009 - September 2010

Senior Validation Engineer / Technical Manager - Smith & Nephew, Memphis,

Tennessee

. Develop new site validation procedure to include (IOQ, OQ, and PQ) for

Memphis Tennessee facility

. Develop the site validation master plan for Memphis TN facility

. Subject matter expert in all validation techniques

. Managed complex validation projects from cradle to grave

. Completed over 300 validation for CNC machinery, CNC lathes

. Trained upstream, downstream, and product development engineers on

validation techniques and specification

. Established criteria for IOQ, OQ, and PQ for Level's 1, 2, and 3

equipment and processes

. Lead the entire China facility through all validation initiatives;

plant audited with no validation findings

. Train the China manufacturing, operations, and supply chain staff on

manufacturing techniques and quality initiatives.

. Develop Validation Master Plan for the Beijing China facility

. Manage validation for the Beijing China facility

. Worked with cross functional team of product development team to

institute the new design transfer and design control procedure

Products produced: femoral, tibia insert, patella, R3, tibia trial head,

etc. These products are associated with hips, knees, shoulders (orthopedics

and trauma)

March 2009 - October 2009 (Contract)

Six Sigma Project Leader - Boston Scientific, San Jose California

. Lead efforts to transfer one facility to another facility within the

validation arena.

. Develop packaging design of experiments to ensure optimal parameters

are utilized with the use of Sencorp Sealers.

. Responsible for all Engineering Studies and OQ protocols for the

transfer project of equipment and processes.

. Update all Manufacturing Practice Instruction thru the use of PDM and

SAP.

. Products involved in transfer: EZ Filter wire and Bent Tips products,

Polar Catheter and Blazer Catheter and Stent products.

. Project leader for PQ and PPQ validation activities

September 2008 - February 2009 (Contract)

Validation/Project Manager - Terumo Cardiovascular-actively involved in all

validation activities.

. Lead all chemistry lab transfer validation efforts between facilities

(Tustin, CA to Ann Arbor, Michigan)

. Wrote validation master plan for all equipment and processes for the

transfer of laboratory equipment. Developed all validation activities

to include (IQ, ES, OQ, and PQ)

. Lead all pFMEA and dFMECA efforts for the transfer.

. Develop shipping and transportation criteria for the shipping

qualification for the transfer (OQ, and PQ) activities.

Chemistry involved in this transfer is pH, K+, CO2, and O2. Team member

help develop validation and functional testing for gamma sterilization.

Worked with outside vendor to perform full compliance of laboratory fume

hoods, using ASHRAE-110 requirements

March 2008 - September 2008

Lead Validation Engineering - Teleflex Medical (Contract)

. Supported all validation effort, wrote validation master plan for

Mount Holly, NJ facility

. Lead two CAPA and validation efforts that resulted in $6 million

dollar project line.

. Lead all validation efforts (IQ, ES, OQ, PQ) provided technical

support to engineering and operations on all validation and CAPA

activities.

. Worked with PE and PP compounds and characterized materials

November 2007- March 2008

Senior Process Control Engineer/Lead Validation Engineer - Respironics,

Murrysville, Pennsylvania

. Developed all validation activities for electro-mechanical devices

(diagnostics & ventilation)

. Wrote, and developed IQ, ES, OQ, and PQ activities for new facility,

as well as diagnostics and ventilation groups.

. Developed project plans for a facility validation effort-Initalizing,

Planning, Maintaining & Control, Execution, and Close.

. Wrote and performed several different validation activities for the

following projects-eDHR project, Facilities Validation activities

(Project Plan, Work Breakdown Structure, Risk Analysis, etc)

. Wrote and improved statistical sampling procedures.

. Coached, mentored others on validation techniques as well as Six Sigma

Green Belt techniques

. Lead validation team in CAPA activities

October 2006 - July 2007

Validation Engineer/ Six Sigma Black Belt/ Quality Engineer - Smiths

Medical, Gary, Indiana

. Train all engineers in protocol and validation procedures (IQ, OQ, PQ)

. Coach, mentor, and trained employees in statistically analysis,

control charting, six sigma methodologies

. Train leadership team in six sigma methodologies

. Develop validation procedures for both Design and Process validation:

DFMEA's and PFMEA's

. Project Leader for cost improvements to exceed $450,000 annually

. Coach, mentor and train Green Belts in DMAIC methodology

. Train, coach, and mentor engineers in the effective use of DOE's,

FMEAs, QFD's.

. Develop site validation master plan: equipment, systems, utilities,

products, process (MVP, PVP, and VP).

March 2006 - September 2006

Engineering Manager-Medical Device/Extrusion - Teleflex Medical, Jaffrey,

New Hampshire (Contract)

. Developed teams within the engineering and maintenance department

. Successful lead paste/melt extrusion projects-etch systems, etc.: MS

Project 2003

. Successfully developed the Black Belt training program

. Lead all validation activities (IQ, ES, OQ, and PQ). Equipment,

process, and sterilization

. Worked with vendors on screw designs and gear box designs

. Worked with vendors to develop SPC and total line control: Facts

Control Systems, ProE Systems, Laser Line

. Lead and Participated with projects with FEP and PE extrusion and

compounds.

. Testing of PE, PVC with a moisture analyzer

. Performed testing with FTIR technology to determine chemical compounds

. Developed numerous DOE's to improve process capabilities: Minitab

2003.

The products most familiar with Teleflex Medical are as follow: PTFE, ETFE,

FEP, Pebax, Polycarbonate, ABS, PEEK

May 2005 - March 2006

Product/Process Engineer - OFS, Inc., Carrollton, Georgia

. Strategically developed capacity and facility planning for entire

manufacturing operation

. Development of Product Cost thru the use of SAP and Oracle

. Increased line capacity by 50% for products with the switch of a

different PVC compounds

. Reduce fiber yield by 25%

. Led a successful 6 Sigma initiative to improve the quality of Premises

cable jacket. Customer issues with jacket integrity were reduced from

6.3 issues per month (rolling 3 month average) to 2.1.

. Led efforts to mistake-proof manual processes, develop 5S

teams/roadmaps, and implement quality circles

. Developed tooling program and reduce tooling cost by 15%

. Responsible for the introduction of new compounds and updating of all

material specifications

. Revise and streamline all manufacturing layout procedures.

. Programmed and Installed TS-5000 system for all extrusion lines, a

flaw detection device and SQC monitoring, Designed and implemented

library functions to monitor process quality monitoring and

improvements: decreased customer complaints by 30%

. Installed N2 on two extrusion lines, increase capability analysis by

25% Cpk's.

. Developed a supplier qualification and evaluation system in order to

determine where supply chain weaknesses exist and to address them

through supplier development or reallocation. Developed an incoming

materials database to provide real-time status of material and quality

improvement data

March 2003 - December 2004

Manufacturing Engineer / Quality Engineer - ACMI, Racine, Wisconsin

. Validated Multivac Fill, Form, and Seal Packaging Machine, DOE

performed

. Designed and developed all manufacturing processes based on cGMP

principles: 21 CFR Part 210, 211 and 820.

. Developed parameters to control raw material process

. Developed new processes on Killion KTS-125 extrusion operation...

. Supported Entire Production Operation-Killion Extrusion (1, and 2 )

. Developed Tec flex Process to run stents inhouse-(sof-curl,

lithostents, double-pigtail, etc)

. Oversaw all raw material disposition, work with vendor to establish

(Melt Flow Index) MFI

. Worked with Alpha Gary to develop octal free, DOP free plasticizer--

DEHP

. Improved productivity by 22%, reduced headcount by 3 individual,

streamlined operations Trained team members in various Six Sigma tools

and methodologies such as project scoping, measurement systems

analysis, failure mode and effects analysis, process mapping,

capability analysis, design of experiments, lean management, ANOVA,

full/2k/fractional factorial design, Lean/Kaizen, response surface

design, EVOP/PLEX, etc.

. Developed a supplier qualification and evaluation system in order to

determine where supply chain weaknesses exist and to address them

through supplier development or reallocation. Developed an incoming

materials database to provide real-time status of material and quality

improvement data

April 2000- February 2003

Plant Operation Manager (Contract Position) - US Filter Corporation,

Indianapolis, Indiana

. Reduced resin cost by 25% with cross regeneration resin

. Implemented GMP, QSR program throughout the organization

. Responsible for FDA validation protcol (IQ, OQ, PQ) Established Eli

Lilly validation process

. Increased productivity by 35%, reduced inventory turns with

implementation of cycle counting.

. Responsible for the following departments: Production, Quality &

Inventory Control, EHS, and Maintenance.

. Responsible for the entire plants FDA, EPA, and OSHA regulations

March 1996 - March 2000

Other employment opportunities: Belden Wire and Cable, Stowe Woodward, Sun

Belt Plastics, and General Electric.

Education: University of Liverpool (LLM in Intellectual Property and

Patent law) Anticipated Graduation

December 2015

Capella University - PhD in Organizational and Leadership August

2010

Indiana Wesleyan University-MBA (Master of Business

Administration), August 2003

Louisiana Tech University, Ruston Louisiana

Master of Science in Chemical Engineering, February 2000

Final Research Project: The Enhancement of the Bubble Stability

in Polyethylene Blown Film through Polymer Rheology and the

Extrusion Process

Bachelor of Science in Chemical Engineering, August 1998-GPA

3.1/4.0

Continuing Education: Stanford University Advance Project Management

Certificate

Smarter Solutions-Six Sigma Master Black Belt (March

2008)

Quality for Training (QAI) Six Sigma Black Belt

(CSSBB)

Villanova University-Six Sigma Black Belt (July 2005)

PMP - PMI Institute (IUPUI) 2005

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