Quality Assurance Control
Resume:
Kenneth B. Lipkin
**-** ***** ******, ******* Point, NY 11356
********@*****.***
Quality Control/Quality Assurance professional with experience with ISO
9001:2008, ISO 13485:2003 (medical device) and FDA QSR 21 CFR 820 quality
standards. Interact with third party quality audits including
recertification to ISO requirements.
Regulatory Affairs/Quality Assurance/Document Control Manager October 2008
- September 2012
Propper Manufacturing Company Inc., Medical Device Division
Long Island City, NY
. Complete knowledge of ISO 9001:2008 Quality Management System -
Requirement
. Complete knowledge of ISO 13485:2003 Requirement for Regulatory Purposes
for the design and manufacture of Medical Devices.
. Complete knowledge of 21 CFR 820, Quality System Regulations for
Medical Devices.
. cGMP Knowledgeable
. Responsible for implementing established policies and procedures relating
to the inspection and/or testing of raw materials, components, in-process
and finished goods.
. Responsible for assuring that all QC procedures are correctly performed.
. Supervised maintenance of all device history files.
. Implemented routine inspection and test programs.
. Make recommendations for improving the quality of the products
manufactured.
. Make recommendations for improving quality control procedures.
. Direct liaison to the United States FDA, Health Canada, Medicine and
Healthcare Regulatory Agency (MHRA), ISO Registrar.
. Maintain and assist in the development of the Device Master Record files
[21 CFR 820.181].
. Maintain the controlled document system, including change orders [21 CFR
820.40].
. Perform test instrument calibrations and inspections to assure accuracy
and precision as required. Maintain calibration records.
. Assist in the development of specifications, test/inspection procedures
and operating procedures.
. Maintain QA manual, procedures manual and forms manual. Develop
procedures and forms, as required.
. Developed and wrote Business Continuity Plan
. Developed and wrote Employee Safety and Evacuation Plan
. Assure that all changes to specifications and other controlled document
are properly approved.
. Assure that working copies of the current revisions of controlled
documents are properly placed.
. Maintain the controlled document system in compliance with ISO, FDA and
all other relevant standards and regulations.
. Conduct internal quality audits per ISO and SOP requirements.
. Obtained and maintained Small Business status as received from the Small
Business Administration.
. Obtained and maintained Women Owned Small Business Self Certification
status as received from the United States Government.
Quality Control Manager/Shop Manager (Consulting Project) April 2008
-September 2008
Felix Storch Inc./Summit Appliance Division
Bronx, NY
. Composed Quality Control manual in accordance with ISO 9001:2000.
. Conducted in-house training seminars on basic quality control.
. Managed mechanics in Customization Assembly Department.
. Conducted research and development projects as well as new product
development.
. Conducted research in reference to requirements necessary to meet Energy
Star compliancy.
. Developed products as per the requirements of the Americans with
Disabilities Act (ADA).
Plant Manager June 2004 -December 2007
Master Metal Polishing Company
Woodside, NY
. Managed all aspects of Plant Operations: Including Shipping/Receiving,
Quality Assurance, Plant Budgeting and direct supervision of ten
employees
. Designed a new scheduling system that maximized production capabilities
by creating a more efficient flow of materials and use of manpower. This
in conjunction with a new forecast model provided greater production,
faster turn times, less rejected material and tighter controls on deliver
dates. These changes resulted in a 30% reduction in turn times and a 20%
overall profit increase.
. Established a comprehensive client relation program that enhanced all
aspects of our professional dealings with our customer base. The
resulting gain in trust and confidence let to a 15% increase in new
orders.
. Established a production forecast program that lead to an increase in
overall productivity in all departments with a smoother and speedier turn
on customer orders.
. Provided client relation services to troubled accounts and opened
communication with accounts increasing client confidence, satisfaction
and loyalty.
. Started a training and incentive program that decreased rejected product
and increased productivity resulting in higher profits and the ability to
bid jobs lower increasing contract bid win ratio.
. Responsible for all purchasing based on a three price system.
. Assisted in the implementation of LEAN manufacturing and Five S Factory
Makeover.
Director of Quality May 1999-June 2004
Master Metal Polishing Company
Woodside, NY
. Responsible for all aspects of in-house quality including but not limited
to anodizing, powder coating, chromate and passivation.
. Assisted in the implementation of ISO 9000:2001.
. Wrote an ISO 9000:2001 Compliant Quality Assurance Manual.
. Maintained ISO 9000:2001 through scheduled audits.
. Wrote anodizing, chromate and passivation process manuals.
. Designed all forms associated with ISO 9000:2001.
Senior Quality Control Engineer October 1996-March 1999
Display Technologies
College Point, NY
. Established product specifications on existing products.
. Established in-coming, in-process and finished goods inspection
procedures.
. Established a vendor surveillance program.
. Established a field complaint response procedure.
. Established load and stability ratings on P.O.P. displays in conjunction
with an independent testing laboratory.
. Liaison between Display Technologies and manufacturing subcontractors to
insure the timely transfer of information.
. Assisted in implementation of ISO 9000 program.
. Maintained ISO 9000 at the vendor level.
Facilities Engineer July 1993-June 1996
Eastern Safety Equipment Co. Inc.
Maspeth, NY
. Certificate of Fitness G-35 - N.Y.C.F.D. (Certificate No. 6215502)
. Chairman, Safety Committee
. OSHA Compliance Officer
. Haz-Mat Officer - Haz-Mat Response Team - First Responder
. IT Administrator
. Implemented lockout/tagout safety program.
. Implemented and maintained bar code (UPC-A and Interleaved 2 of 5)
program.
. Provided technical support in the planning and construction of 40' x 50'
mezzanine work platform, including electrical requirements.
. Aided in the design and upgrading of compressed air network.
Quality Control Manager 1991 - July 1993
Eastern Safety Equipment Co. Inc.
Maspeth, NY
. Directed activities of four quality assurance inspectors.
. ANSI Z97.1-1989 - Requirements for Protective Eyeware.
. ANSI Z89.1-1986 - Requirement for Protective Headware.
. Wrote Quality Assurance manual
. Interfaced with DCMAO and SQAR
. Liaison to Safety Equipment Institute
. Implemented receiving procedures
Quality Control Engineer 1985 - 1991
Bulova Technologies
Valley Stream, NY
. Directed the activities of inspectors from various technical disciplines.
. Interfaced with DCMAO and SQAR.
. Reviewed and maintained customer Technical Data Packages.
. Conducted in-house classes on Statistical Process Control.
. Maintained and coordinated use of Datamyte Data Collections Systems.
. Preparation and analysis of costs related to quality.
. Maintained and updated Quality Manual.
. Conducted on-site vendor Quality surveys.
. Novell Network co-administrator.
. Material Review Board member.
. Initiated internal and vendor corrective action.
. Responsible for implementation and maintenance of Inspection Instruction
Cards.
. Reviewed and provided input concerning customer quality requirements.
. Processed Discrepant Material Reports.
. Initiated and maintained Quality Assurance Instructions.
Additional Information:
Brooklyn College, BSMEWell defined knowledge of Mil-C-5541 (Chemical
Conversion), Mil-A-8625 (Anodizing), Mil-Q-9858 (Quality), Mil-I-45208
(Inspection Requirements).
Highly proficient in the use of Microsoft Office Suite 2003 & 2007.
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