PROFESSIONAL PROFILE

Fifteen years professional work experience as a Manager and Engineer in ISO 1348
5:2003, cGMP 21 CFR Part 820 (FDA Regulation), 93/42/EEC MDD (EU Regulation), SO
R/98-282 CMDCAS (Health Canada Regulation) and ISO 9001:2008 manufacturing envir
onments. Advanced Graduate Certification in Statistical Quality Control, Six Si
gma Green Belt Certification, Reliability Certificate in Life Data Analysis and
a Bachelor of Science in Industrial Engineering. Possess the vision necessary t
o develop and implement successful action plans, the experience to build and lea
d an effective team, and the drive and dedication to follow-through to a success
ful conclusion. Substantial experience with manufacturing and design quality ma
nagement of FDA and MDD class IIa and IIb medical devices. Motivated, detail or
iented, self-starter with a track record of successfully implementing quality ma
nagement systems and leading business process improvement initiatives. Extensiv
e experience in:
* Quality Management / Planning * Design Controls * Purchasing / Supplier C
ontrols
* Hiring, Supervision and Training * Customer Feedback Management * Product R
ealization (APQP)
* Validation (Product and Process) * Risk Management (ISO 14971) * Auditing (
Internal / External)
* Documentation Controls * Process Controls * Change Management

PROFESSIONAL EXPERIENCE
Quality Assurance Manager and Validation Manager
OBERG MEDICAL (a subsidiary of Oberg Industries Inc.) - Freeport, Pennsylvania
Precision custom metal manufacturer supporting large OEMs in the orthopedic, lap
aroscopic and endoscopic marketplaces with medical device implants and instrumen
tations; $20 million in annual sales. (www.oberg.com) (January 2010 - Present)
Validation
Developed and implemented Medicals Master Validation Plan (MVP). In conjunctio
n with the MVP, successfully developed and implemented a Master Validation Repor
ting System (MVRS) to internally and externally communicate Qualification / Vali
dation status, priorities and provide traceability.
o Millions of dollars of orders were retained as result of leadership, vision, c
ustomer communication techniques and compliant approach throughout conduction of
the MVP.
Developed and implemented the Corporate Qualification / Validation Procedure an
d Risk Management Procedure to govern and assist in conduction of required Equip
ment Qualifications and Process Validations.
Developed and implemented all required Qualification / Validation templates (eq
uipment installation qualification EIQ, equipment operational qualification EOQ,
process operational qualification POQ and process performance qualification PPQ
), which were populated for conduction of the required qualification / validatio
n activity.
Developed and implemented a Process Requirement Specification Procedure, which
was utilized to systematically capture all equipment, process and product requir
ements to ensure a compliant equipment qualification and process validation.
Successfully conducted and reported on the following Special Process equipment
qualifications and process validations: Cleaning, Passivation, Heat Treating / T
empering, MIG Weld and Laser Weld.
Successfully conducted and reported on the following Critical manufacturing equ
ipment qualifications: Multi-Axis Vertical and Horizontal Mills, Swiss Turning M
achines, Wire EDM Machines and Plunger EDM Machines.
Generated work instructions in collaboration with validation efforts. All Spec
ial Processes received a work instruction following successful validation.
Purchasing / Supplier Control
Developed and implemented the Corporate Supplier Evaluation and Monitoring Proc
edure in support of the Customer Driven goal of a risk based Purchasing / Suppli
er Control system.
o Millions of dollars of business were awarded to Oberg Medical as result of lea
dership, vision and customer communication techniques.
* Fundamentals of the risk based procedure include:
Risk based classification of Suppliers (Critical, Major or Minor); driven by su
pplier scope.
Development of supplier requirements based on risk classification assessment.
Successful development and implementation of a Supplier Quality Agreement.
Transcend Oberg Medical Advanced Product Quality Plan(s) to the supplier.
Development of an Approved Supplier List (ASL).
Product Realization / Process Control
Educated and trained the medical management team toward the requirements and be
nefits of Product Realization to assist in the successful development and implem
entation of the Advance Product Quality Planning Procedure.
Successfully developed and implemented the Advance Product Quality Planning Pro
cedure, which ensured that a quality plan and manufacturing plan was developed a
nd intact prior to releasing jobs to the floor for manufacture.
Successfully developed and implemented a risk based and statistically sound Rec
eiving Inspection Procedure, In-process Inspection Procedure and Final Inspectio
n Procedure to ensure that the Quality Plan and Manufacturing Plan were upheld a
nd only acceptable product was released to the customer.
Quality Management System (QMS)
Mentored the Executive Management Team and Medical Management Team toward the r
equirements of ISO 13485:2003 and 21 CFR Part 820 that differ from ISO 9001:2008
; the resources required to support the new QMS (development and sustaining reso
urces), and the cost and timing for the phases of implementation and certificati
on.
Identified and retained a registrar for ISO13485:2003 certification.
Effectively communicated the scope of the certification and the readiness audit
details internally and with the registrar.
Developed and implemented quality and procedures manual in compliance with ISO
13485:2003 and 21 CFR Part 820.
Corrective and Preventive Action
Developed and implemented a Corrective and Preventive Action Procedure.
Permanently and effectively closed 38 Corrective Action Reports (CARs) using an
8D approach and communicated the response to the customer(s) if applicable.
o Combined open (CARs) with similar fail modes or subject matter, resulting in 3
8 individual (CARs) no longer being required. The work was combined into (22) C
ARs.
Quality Engineering Manager and Validation Manager
SIGMA LLC (a subsidiary of Baxter) - Medina, New York
Designer and manufacturer of the wireless technology Smart Infusion Pump; $200 m
illion in annual sales. (www.sigmapumps.com) (June 2009 December 2009)
The corporate Statistical Techniques Procedure was cited through a FDA third pa
rty audit for inadequate statistical sample size determination. Developed and i
mplemented a risk based corrective action to the audit finding and provided cor
porate training, resulting in a common approach to sample size requirements for
validations etc
Developed the process validation plan and supporting documentation (POQ and PPQ
) for a $1.6 million lean manufacturing line expansion. The equipment received
full (EIQ), equipment specifications were tested throughout (EOQ) conduction.
 Responsible for the design control activities and design control chronology of
two new products (Pain Management Pump and Syringe Pump). Worked directly with
the new project teams from planning, design inputs, design outputs and the preli
minary portions of verification and validation.
Responsible for the design validation of three significant hardware design chan
ges and two significant software changes.
Participated in risk analysis activities (i.e. risk plan PHA, DFMEA and PFMEA).
Ensured software bug list was properly updated into risk management system.
Quality Assurance Engineer
GAYMAR INDUSTRIES INCORPORATED (a subsidiary of Stryker Corporation) - Orchard P
ark, New York
Designer and manufacturer of Pressure Ulcer Management Product and Temperature M
anagement Products; $100 million in annual sales. (www.gaymar.com) (August 2006
July 2009)
Responsible for reviewing the Technical Files of the CE marked products for con
formance and ensuring that the supporting Declarations of Conformance were accur
ately documented to support the associated product. Short comings of the review
were documented and communicated for corrective action.
Internal audit team member responsible for the conduction and report generation
of internal audits against the requirements of ISO 13485:2003, QSR 21 CFR Part
820, MDD 93/42/EEC and CMDCAS SOR/98-282.
New product team representative to ensure that the design controls and supporti
ng technical documentation was properly established and documented in support of
the applicable requirements (13485:2003, QSR 21 CFR Part 820, MDD 93/42/EEC and
CMDCAS SOR/98-282).
Provided corporate training in the areas of Problem Solving and Statistics.
Developed corporate reliability procedure (DFR) and led all reliability efforts
for new product development and legacy products.
Mentored statistical knowledge to engineering staff as requested (i.e. sample s
ize determination, verification / validation testing analysis, GR&R studies, DOE
studies, hypothesis testing, reliability analysis, warranty prediction models e
tc)
Ensured that the design control stages (planning, design input, design output,
verification, validations and design transfer) were properly adhered and documen
ted on three new product launches.
Worked with IT to revise, validate and implement the Non-conformance Reporting
System, Customer Complaints / Feedback System and Returned Goods System to elect
ronically control the procedures for efficiency, trending and costing.
Quality Assurance Engineer
PRESTOLITE LEECE-NEVILLE - Arcade, New York
Designer and manufacturer of heavy duty Alternators and Starter Motors to commer
cial and government markets; $120 million in annual sales. (www.prestolite.com)
(June 2005 July 2006)

Quality Assurance Manager

DIMAR MANUFACTURING - Clarence, New York
Custom sheet metal manufacturer supporting the aerospace, medical, transportatio
n and military markets with; $15 million in annual sales. (www.dimarmfg.com) (A
pril 2000 June 2005)
Manufacturing Engineer / Quality Assurance Engineer
GREATBATCH Clarence, New York
Designer and manufacturer of implantable power sources utilized in the implantab
le pacemaker; $500 million in annual sales. (www.greatbatch.com) (May 1994 Marc
h 1999)
EDUCATION / CERTIFICATION
BACHELOR OF SCIENCE DEGREE, Industrial Engineering
State College of New York at Buffalo
Buffalo, New York
ADVANCED GRADUATE CERTIFICATION STATISTICAL QUALITY CONTROL
Rochester Institute of Technology (RIT)
Rochester, New York
* Statistics I * Statistics II
* Design of Experiments (DOE) I * Design of Experiments (DOE) II
* Acceptance Sampling * Statistical Process Control
* Quality Engineering * Quality Management
MINOR TECHNOLOGY EDUCATION
State College of New York at Buffalo
Buffalo, New York

SIX SIGMA GREEN BELT CERTIFICATION

State University of New York at Buffalo (UB)
Buffalo, New York
(March 2006)
ISO 13485:2003 AUDITOR CERTIFICATE
SMG Training Professionals
(October 2010)
RELIABILITY LIFE DATA ANALYSIS (LDA) CERTIFICATE
Relia-soft Training Professionals
(February 2008)

TECHNICAL SKILLS
* Windows 2000, XP * Microsoft Office
* Minitab
* QC Calc * Weibull ++7 * Acc
ess
* Visio * Microsoft Project *
FMEA Pro
References Available Upon Request