Engineer Quality

SANDY COWLES

**** **** **** **** ? Brooksville, FL 34601

Contact: 352-***-**** ? abiceq@r.postjobfree.com

MANUFACTURING & QUALITY ENGINEERING MANAGEMENT

Six Sigma /LEAN certified; evaluates and improves corporate procedures

to position organizations for continued global success

V Strategic leader offering 18+ years of progressive experience within the

medical device, pharmaceutical, aerospace, and DOD arenas, directing

cross-functional teams to complete complex initiatives on time and to

specification.

V Expert in quality control, design/development, and AS/ FDA/ISO

compliance, delivering innovative solutions to realign underperforming

areas, disparate processes, and internal capabilities in stride with

enterprise direction.

Core Strengths

Team Building . Regulatory Compliance . Project Management . Lean

Manufacturing

Systems Engineering . R&D . Quality Control Management . Global

Relationship Building

MAJOR ACHIEVEMENTS

Continuous Improvement/Quality Control:

. Designed a new delivery feature for Bausch & Lomb Surgical's ophthalmic

drug/device, Ocucoat, amplifying product sales from $600K to $1.5M in the

first year while minimizing customer complaints.

. Created procedures and quarterly tests to validate disposable surgical

packs in compliance with gamma radiation regulations without disturbing

sterile fields. These new developments were presented at the 1999

Advancement of Medical Instrumentation (AAMI) sterilization conference.

. Orchestrated a centralized documentation system to reduce GE Healthcare's

required procedures across Mexico, UK, and Florida sites 50%.

. Led ECAD S/W tool replacement/update initiatives, identifying low cost

vendors and completing initiatives on time and $20K under budget.

. Headed a GE process team to experiment with and set up a manufacturing

process for the heat treating of vanadium cobalt material used in the

generating systems of aircraft. This was accomplished by using heated

hydrogen in a vacuum.

Project Management:

. Recruited to direct manufacturing, quality, compliance, and regulatory

projects to recover Baxter Healthcare from a failed 2004 FDA audit.

Built a readiness team and established inter-departmental relationships

to improve product design and development procedures, delivering

presentations to corporate management and the FDA in the first and second

quarters of 2007 with favorable results.

. Selected to represent Bausch & Lomb at the 1999 annual AAMI sterilization

meeting in Washington DC, co-developing and voting on international laws

concerning sterilization techniques.

. Restructured quality system procedures in compliance with ISO and QSR

requirements, building relationships with BSI to secure the CE mark for a

majority of GE Healthcare product lines.

. Managed and implemented several automated welding processes for GE

aerospace, Olin Defense and White Consolidated Industries. This included

MIG, TIG, SubArc, electron beam, etc.

. Headed a team at GE Mexico to create and set up wave soldering equipment

for the manufacture of PCB boards and replace the outsourcing company.

This led to a cost savings of $250K per year in the first year of

development

Continues...

SANDY COWLES

C: 352-***-**** ? abiceq@r.postjobfree.com ? Page 2

CAREER PROGRESSION

Contract Engineering Services - contracts include: [2005-present]

. Sr. QE-Regulatory Compliance Associates, Inc. (2010-present)

Contracted to review the quality system, tech files for R&D &

sustaining products

and re-write (if required) the requirements for FDA, ISO and MDD

2010 approval.

. Senior Quality Engineer-Smith & Nephew (2008-2009)

Contracted to maintain the Quality System and, interface with

customers and other S&N employees globally during the transfer of all

wound care products to other sites during the closing of the Largo,

Florida manufacturing facility. This included the development of the

CAPA process using complaints as a basis.

. Senior Quality Engineer/Quality Analyst-Jabil Circuit (2007)

Collaborated with engineers and managers to complete ISO medical

device projects for GlaxoSmithKline and

Siemens. Reviewed IEC/UL/MD standards and corporate quality systems

to ensure compliance with FDA medical design controls and testing

requirements.

. Senior Quality/Principal Engineer ( corporate) Baxter Healthcare (2005-

2007)

Recruited to mitigate major defects identified in a 2004 FDA audit,

heading manufacturing, quality, compliance, and regulatory projects.

Interfaced with quality, design, and sustaining/manufacturing to

improve design change, implementation, testing, and validation

procedures. This included the development of the SCAR, CAR, and CAPA

processes.

Also performed DOE on complaints of bacteria remaining in the tubing

after cleaning. Process showed the tubing to be too rigid and

another, more pliable tubing was used between the clinic hookups and

the Arena(medical device) hookups

Manager of Engineering Services [1999-2004]

GE HEALTHCARE

Promoted from senior quality/systems development engineer to direct teams

of up to 15 members, including technical writers, engineers, and technical

assistants.

o Managed the conversion of GE Healthcare's documentation and ECAD

applications from a generic system to Agile/Oracle and

PADS/VeriBest.

o Performed IQ and OQ for agile and veribest software validation.

Senior Staff Engineer/Quality Engineer/Project Engineer [1992-1999]

BAUSCH & LOMB SURGICAL

Compiled surgical packs for gamma radiation sterilization. Led efforts to

register the company's pharmaceutical products in 20 foreign countries.

o Developed the company's first audit scheduling system for ISO and

FDA approval.

o Performed site change validation per IQ, OQ, and PQ of the EtO

Getinge sterilizer including mapping for chamber temps and BI

placement.

Welding Engineer/Materials Laboratory Manager, NAVSEA certified,

COPES-VULCAN (WHITE CONSOLIDATED INDUSTRIES/SPX)

Welding Engineer/Materials Engineer & Manager, GENERAL ELECTRIC

CREDENTIALS

BS in Business/Metallurgical Engineering minor, Michigan Tech University

Six Sigma LEAN Green Belt Certified, GE Medical Systems

Cambridge Who's Who Registry of Executives, Professionals and

Entrepreneurs, 2009-2010

APICS and ASQC MEMBER - 2009-2010

Specialized Training: Welding Engineering . Computer Sciences. Lean

Manufacturing

NDT Level II Certified Instructor . Technical Writing. Microbiological

Courses

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