Director - Biotech Resume Search
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Director Resume


Desired Industry: Biotech SpiderID: 50402
Desired Job Location: Boca Raton, Florida Date Posted: 4/26/2011
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 50-75%
Highest Degree Attained: MBA Willing to Relocate: Undecided


Objective:
Leadership position with a Quality focused
organization


Experience:
City Power Marketing, LLC

Power Trading Company
Ft Lauderdale, FL - October 2009 to
Present.

Partner

Partner/Owner of privately held
wholesale power trading organization
Traded energy in specific
virtual and physical markets
Managed day to day operations of
trading office
Managed relocation of company
headquarters to present Florida location
Managed satellite financial
office in New Jersey
Served as legal liaison and
regulatory compliance officer
Maintained compliance with
regulatory and licensing requirements
Managed and negotiated contracts
with key suppliers
Investigated opportunities for
expansion of business and new markets
Managed rapid software
development and validation process
Performed energy market analyses
and statistical evaluations


Medtronic Corporation

Spinal and Biologics Business
Medical Device Manufacturer January,
2003 to September, 2009.

Director of Product Quality
Medtronic Spinal and Biologics Global
Headquarters Memphis, TN - July, 2006
to September 2009.

Managed Post-market Risk
Management process for the Business Unit
Maintained overall
responsibility for worldwide complaint
handling and Medical Device Reporting
processes
Planned and implemented
worldwide Field Actions (Recalls)
Developed and communicated
instructions to sales force for Field
Action Activities
Assured compliance with FDA
reporting requirements for Medical
Device Reports per 21CFR803 and Field
Actions per 21CFR806
Managed Supplier Quality
Department
Acted as liaison with FDA and
Notified Body on quality issues
Interfaced with corporate and
third party auditors

Senior Manager of Quality Systems
Medtronic Spinal and Biologics Warsaw
Manufacturing Warsaw, IN January
2004 to July, 2006.

Responsible for development,
deployment and maintenance of quality
systems to assure regulatory and quality
compliance with FDA Regulations, ISO
13485, ISO 9001, CDMCAS, etc.
Managed validation and
deployment of TrackWise Software
Managed Supplier Quality program
Managed product complaint and
return process
Managed Corrective and
Preventive Action Process
Interfaced with FDA, corporate
and third party auditors
Managed Internal Audit program
Managed Document Control
function
Maintained responsibility for
quality records including Device Master
Records, Device History Records and Item
Masters
Provided IDE, PMA and 510k
documentation for corporate submissions
Re-engineered Return
Authorization system leading to improved
visibility, tracking and response to
complaint related returns

UTI Corporation (now Accellent)
Contract Manufacturer of Medical Device
Components and Assemblies: June 1994 to
December 2003.

Director of Quality Assurance Star
Guide, Arvada, CO - January, 2001 to
December 2003.

Responsible for Quality
Operations at three divisions of UTI
Star Guide:

o Star Guide - Arvada, Colorado
o Star Guide Europe - Galway,
Ireland
o Micro Guide Tehachapi,
California

Responsible for Quality Systems
including continual Quality System
upgrades and enhancements
Reduced internal reject rate
from 11% to 0.5 % through implementation
of preventive measures
Reduced complaint backlog from
over 12 weeks to less than three weeks
Implemented Quality Systems for
European start-up facility leading to
ISO 9001:2000 registration
Implemented GMP based Quality
Management Systems for FDA compliance
Maintained primary
responsibility for and ISO 9001
registration and Regulatory Affairs
Participated in corporate
assessments of potential M&A candidates

Field Sales Engineer, UTI Midwest
territory - January 1999 to January
2001.

Performed Sales and Marketing
activities for 160,000 square mile
territory in Midwestern US and Canada
representing five divisions of UTI
Corporation:

o Uniform Tubes
o Micro Med Machining
o Spectrum Manufacturing
o Stent Technologies
o Utitec

Maintained technical expertise
in all company technologies and
capabilities
Developed new business and
expansion of existing accounts
Developed and maintained
relationships with existing and
potential customers
Communicated and demonstrated
company capabilities and products to
customers
Consulted and collaborated with
customers in product design and
development
Represented company at trade
shows
Maintained ongoing communication
with business units regarding
development programs and order status
Analyzed territory sales trends
and developed strategies to maximize
territory growth

Quality Assurance Manager Collegeville
Division, June 1994 to January 1999.

Reduced Complaint backlog from
18 months to 30 days
Maintained primary
responsibility for administration and
effectiveness of plant-wide ISO 9001
Quality Management System
Managed multi-site Internal
Audit program in compliance with ISO
9000 and ANSI Q10011
Served as primary interface on
all Quality issues including second and
third party audits
Chaired Material Review Board
and Quality Steering Teams
Trained Internal Audit Teams
Coordinated Management Reviews
of the Quality System

Philadelphia Gear Corporation

Designer and manufacturer of precision
gears and power transmission devices for
industry.
King of Prussia, PA: April 1993
to June 1994.

ISO 9000 Program Manager

Managed overall Corporate ISO
9001 Registration Program
Developed and implemented
documented Quality Management System
Lead Internal Quality System
Audit teams for corporate headquarters
and subsidiaries
Coordinated implementation of
Corrective Actions for Internal Audit
findings
Conducted ISO 9000 training of
management and union labor force
Served as primary interface for
second and third party audits

National Vulcanized Fiber Company
Producer of paper and vulcanized
fiber for industrial applications.
Primary Products Division, Yorklyn, DE:
March 1992 to April 1993.

Quality Assurance Manager

Managed Division ISO 9002
registration program
Maintained overall
responsibility for quality system and
quality of products
Supervised Quality Control
Laboratory
Coordinated division SPC program
Performed Internal Quality
System Audits
Acted as primary interface on
technical and quality issues
Coordinated Corrective Action
and Continuous Improvement projects

Thiokol Corporation
Manufacturer of solid propulsion (rocket
motors) and associated ordnance for
tactical/strategic military and space
applications.
Aerospace Division, Elkton, MD:
July 1985 to October 1991.

Program Manager, July 1987 to
October 1991.

Planned and coordinated all
aspects of assigned NASA, military and
commercial aerospace programs
Lead project teams of technical
specialists to assure that all
technical, quality, schedule and profit
objectives were met
Administered combined program
budgets in excess of $ 20 Million
Coordinated Continuous
Improvement projects saving company an
estimated $300K per year
Awarded certificate of
commendation from customer for
outstanding support to the Delta II
rocket program

Quality Assurance Engineer, July 1985 to
July 1987.

Coordinated supplier quality
improvements on assigned programs,
reducing incoming quality
nonconformances by 45%
Assured compliance to MIL-Q-9858
Quality System and all specific
contracted quality requirements
Established Quality Assurance
Provisions, standard inspection
requirements, and acceptance criteria
Chaired Material Review Board
and Corrective Action Board
Performed internal and supplier
audits
Performed source inspection of
critical components and processes at
supplier facilities
Maintained surveillance and
conducted resident source inspection at
key supplier facilities


Education:

Bachelor of Science in Mechanical
Engineering Technology
Temple University, Philadelphia, PA: May
1985

Masters of Business Administration
Wilmington College, Wilmington, DE: May
1989

Post-Graduate Certificate in
International Business Management
St. Joseph's University, Philadelphia,
PA: June 1998


Affiliations:
Regulatory Affairs Certified
(RAC) by Regulatory Affairs
Professionals Society (RAPS)
Senior Member American Society
for Quality (ASQ)
ASQ Certifications:

CQE - Certified Quality Engineer
- # 35381
CRE - Certified Reliability
Engineer - # 6063
CQA - Certified Quality Auditor
- # 15737
CSQE - Certified Software
Quality Engineer - # 3483
CBA - Certified Biomedical
Auditor - # 123
SSBB - Certified Six Sigma Black
Belt - # 883
CHA - Certified HACCP Auditor -
# 408
SSGB - Certified Six Sigma Green
Belt - # 365
CMQ/OE - Manager of Quality/Org.
Excellence - # 907
CQPA - Certified Quality Process
Analyst - # 202
CQT - Certified Quality
Technician - # 19556
CQIA - Certified Quality
Improvement Associate- # 4081
CCT - Certified Calibration
Technician - # 392
CQI - Certified Quality
Inspector - # 12017

Among most certified individuals
worldwide by ASQ:
http://www.asq.org/media-room/press-
releases/2010/20101028-asq-recognizes-
most-certifications.html


Skills:
High energy professional experienced in
Quality Assurance, Regulatory
Compliance, Continuous Improvement and
Operational Excellence. Skilled in all
aspects of Management with a strong
background in Quality Improvement,
Systems Implementation, ISO 9000, ISO
13485, ISO14971, FDA Regulations, Lean
Manufacturing and Six Sigma. Excellent
organizational, planning, problem
solving and communication skills.
Strengths include customer relationship
management, change management,
continuous improvement, statistical
methodology, project management and
organizational development.


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