Vice President Quality Assurance Regulatory Affairs-Life Sciences - Bi
Vice President Quality Assurance Regulatory Affairs-Life Sciences - Bi
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Vice President Quality Assurance/Regulatory Affairs-Life Sciences Resume


Desired Industry: Biotech SpiderID: 51005
Desired Job Location: San Diego, California Date Posted: 5/18/2011
Type of Position: Full-Time Permanent Availability Date: Immediatley
Desired Wage: 200000
U.S. Work Authorization: Yes
Job Level: Executive (President, VP, CEO) Willing to Travel:
Highest Degree Attained: Other Willing to Relocate: No


Objective:
- High-powered, talented, and
dynamic executive with extensive
experience in quality assurance and
regulatory affairs compliance.

- Demonstrate keen expertise in
producing innovative plans, strategies,
and initiatives to continuously improve
quality, reduce costs, optimize
efficiency, and improve corporate
productivity.

- Proficient in coordinating all
facets of multiple, complex projects
ensuring on-time, on-budget, and on-
target results while guaranteeing strict
adherence to regulatory standards.

- Well-versed in leading and
training multidisciplinary teams while
maintaining high ethical and quality
standards, professional demeanor, and a
cooperative attitude.

- Possess a keen eye for detail
with proven effectiveness to multitask
in fiercely competitive and fast-paced
environment with dedication to
operational excellence and superior
service.


Experience:
NOTABLE ACHIEVEMENTS

FLEXMEDICAL, a Division of Flextronics
(FORMALLY AVAIL MEDICAL AND PACIFIC
DEVICE) ~ SAN DIEGO, CA: 1990–PRESENT

Vice President of Quality Assurance and
Regulatory Affairs, FlexMedical Jan
2008–Present
Senior Vice President of Quality
Assurance and Regulatory Affairs, Avail
Medical Mar 2000–Jan 2008
Director of Quality Assurance, Avail
Medical May 1998–Mar 2000
Quality Manager, Avail Medical Apr
1996–May 1998
Quality and Engineering Manager, Pacific
Device Jun 1990–Apr 1996

ACTION: Created multi-year quality
strategic plans, which translated into
site objectives, goals, and initiatives.

- RESULTS: Administered more than
$1.5M budgets supporting total quality
organization consisting of 300+ people
across 8 locations. Created initiatives
to consolidate the Quality Management
System (QMS), automate the QMS system,
and drove continuous quality improvement
through the Lean Manufacturing/Kaizen
process.

ACTION: Hired and trained high- and mid-
level quality professionals and
developed them into a high performance
team that achieved the maximum level of
performance.

- RESULTS: Handled quality issue
resolution, quarterly business reviews,
and weekly/monthly meetings. Expertly
managed professionals in the quality
organization and due to exemplary
leadership abilities, most of the
professionals were later promoted into
leadership roles within Business
Development, Plant Management,
Engineering Management, and Program
Management.

ACTION: Conceptualized and implemented a
unified quality system across multiple
faculties in Mexico and China, including
in compliance with ISO-13485 and FDA
QSRs, based on “best practices” which
included elements from the 10 largest
medical device companies along with
accumulated learning of 20+ years of
experience.

- RESULTS: Received excellent FDA
compliance record with 9 consecutive FDA
audits with no significant findings over
a 10-year period.

ACTION: Presided over the implementation
team on a software system (Agile) to
control/automate all company document
changes, Bill of Material (BOM) changes,
Approved Supplier List, and major
elements of the quality system
(complaints, Nonconforming Material
Control (NCMR), and Corrective and
Preventative Action (CAPA).

- RESULTS: Expedited time to
release change order by 50%, achieving
volumes of more than 200 ECOs per month.
Significantly reduced lead times to
deliver products by providing access to
customers for review and approval. Cost-
effectively saved 25% of supplier
audits/maintenance costs by
consolidating the Approved Supplier List
(ASL). Realized 66% reduction in
Nonconforming Material (NCMRs) and 59%
reduction in complaints through monthly
site and corporate consolidated metrics
reports, which drove corrective action
plans.

ACTION: Obtained FDA approval for 510(k)
submissions, which included writing
protocols/reports, creating a
biocompatibility plan, and conducting
sterilization validation activities
(Gamma, eBeam, an Ethylene Oxide (EtO).

- RESULTS: Extended product line
lifecycles, which resulted in the sale
of a high volume product family to
another company. Rendered RA support to
customers on their submissions,
providing a value added proposition to
increase business opportunities.
ACTION: Provided expert oversight in
company’s Lean/Sigma program, which was
aggressively implemented in combination
with selected automated detection
systems and shop floor control software
(MES) to achieve significant quality and
cost improvements.
- RESULTS: Restructured Lean
program to support cost reduction goals
based on quality improvement. Kaizen
events (i.e. projects) provided
documented savings up to $1M annually.

ACTION: Formulated a Cost of Quality
(CoQ) system including the design of
measurement system, monthly reporting,
establishment of goals/targets, and
driving improvement plans.
- RESULTS: Incurred year-over-year
savings on internal costs by 36% in the
highest volume plant and a 47% reduction
in the number of site wide customer
returns. Created goals/targets on
internal scrap, inventory costs of
quarantined material, customer-returned
product, and other costs.

ACTION: Designed and validated a PC
network-based system, which included
monitoring sales orders, prioritizing
production jobs, developing labor
standards, tracking production
efficiencies, and recording quality
metrics.
- RESULTS: Directed the company’s
sales, operations, and quality through
the functions of the system, which was
used for 8+ years before being
supplemented and eventually replaced by
a commercial ERP system

ACTION: Served as a customer liaison for
critical quality-related interfaces,
such as contract review, quality
planning, gap analysis, quarterly
business reviews, audits, and issue
resolution.
- RESULTS: Improved customer
relations by delivering timely and
accurate information. Highly regarded by
the customers and Sales Team through
demonstration of exemplary performance
in delivering informative ideas in a
professional manner.

ACTION: Managed Environmental Control
Monitoring Program that included:
Cleanroom Commissioning/Validation,
Microbial Testing, and Particulate
Testing in compliance with ISO 14644.
- RESULTS: Instituted an internal
test program and obtained compliance to
all applicable standards, which resulted
to an excellent compliance record on FDA
and customer audits.

ACTION: Oversaw all phases of the
sterilization validation/monitoring
program, which include validation
activities, product bioburden
monitoring, and conducting periodic dose
audits/revalidation activities in
compliance with ISO 11135/11137.
- RESULTS: Provided exceptional
service to customer, thus elevating
value proposition and distinction among
competitors.



PRIOR WORK EXPERIENCE

ENGINEERING GROUP LEAD ~ Cipher Data
Products Inc., San Diego, CA
SENIOR MANAGEMENT SYSTEMS SPECIALIST /
SENIOR MANUFACTURING ENGINEER ~ Hughes
Aircraft, El Segundo, CA
INDUSTRIAL / PROJECT ENGINEER ~American
Bentley Laboratories, Irvine, CA
INDUSTRIAL ENGINEER ~ Johns-Manville,
Denver, CO / Corona, CA


Education:
EDUCATION

BACHELOR OF SCIENCE IN INDUSTRIAL
ENGINEERING ~ Rutgers College of
Engineering, Piscataway NJ
Graduated magna cum laude | Tau Beta Pi
(National Honor Society of Engineers)


Affiliations:
----


Skills:
-----


Additional Information:
PROFESSIONAL TRAINING

Six Sigma Blackbelt Training | Lean
Manufacturing Training | ISO 13485:2003
Training by TUV America |
ISO 9000:2000 by the European Quality
Institute | “Basic Fundamentals of
Process Development” |
Good Manufacturing Practices Regulations
by IAT Institute for Applied Technology
“Advanced Electronic Records and
Signatures” by AdvaMed |Validation and
Design Control” by Johnson & Johnson
Medical |
Supplier Quality Systems Requirements by
Ethicon Endo-Surgery
“Biocompatibility Testing for Medical
Devices” by ViroMed Laboratories



COMMUNITY INVOLVEMENT

Participated in home builds in Tijuana,
Mexico with “Homes of Hope” organization

Volunteered to assist church
parishioners who had lost homes during
San Diego 2007 wildfires, other
volunteer work for church including
“Confirmation Sponsor”


Reference:
Available upon request.


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