Steven A.

Norris
135 Azalea Trails Drive Cell (601) 503-6468
Brandon, MS 39047
snbb2422@westpost.net
Seasoned professional with 25+ years experience in quality assurance, production
, and new product launch in the tool and medical device industries. In-depth kno
wledge of cGMP, FDA, ISO9002, ISO 13488 and ISO13485:2003, Lean Manufacturing (K
aizen), Gage R&R, CALIBRATION, SPC, FMEA, DOE, validation, audit, problem resolu
tion, supplier development, customer liaison, and Six Sigma Certified.
ACHIEVEMENTS
Management: Use of Six Sigma methodologies to structure
QA department of 16 employees. Reduce lost work days by 12%
with implementation of machine guarding program. Improve work
flow 20% through restructure of work schedules. Help implement
ISO:13485.
Cost Saving: Reduce budget by 60K/year by combining work stations. Reduce
yearly budget by 100K by restructuring final inspection process.
Reduce scrap with improved operator training. Currently saved
80 Man hours per week by implementing lean practices in inspection
Quality Assurance: Work closely with FDA auditors, maintain certified
Quality systems, led Younquist Medical team in ISO13485:2003 certification, mini
mization of corrective actions, and problem
solving. New product validation and document control.
EXPERIENCE
6/2009- Present QA/RA Manager Spinal USA, Pearl, MS.
Privately held Medical Device Manufacturer producing full line of Spinal impla
nts under their own name. Promoted to Director of Operations 1/2010.
* Responsible for all Manufacturing and Plant Operations, including Quality, Re
gulatory, validations, and manufacturing.
* Report to Board of Directors in a facility of 45 employees.
* Responsible for Forecasting and internal sales.
* Led management team in increasing sales 40% from previous year.
* Oversee new product development
* Led manufacturing team in establishing in house manufacturing.

4/2008- 5/2009 QA/RA Manager Endotec, Orlando, FL.

Privately held Medical Device Manufacturer producing full line of implants und
er their own name. Promoted to Director of Operations 12/2008.
* Responsible for all Manufacturing and QA functions, including validations in
a facility of 45 employees.
* Management representative for FDA and ISO interface and audits.
* Responsible for setting up Sterilization and packaging in house. Company sold
to Korean Bone Bank.
11/2006-3/2008 Quality Assurance Director Youngquist Medical Fort Myers,
FL.
Medical Device start up company. Company specializes in spinal plates, bone
screws, caudal bearings, and spinal instrumentation.
* Report to President in a facility of 50 mployees, responsible for setting up Q
uality System, class 10,000 clean room, purchasing, quoting, and production flow
.
* Responsible for multi plant Quality Systems including Regulatory Affairs, Qua
lity Engineering, MRB, and institution of NMR. Plant wide responsibility for tra
ining and training records.
* In charge of Quality for 2 plant structure. Plant closed on 10/31/07.
4/2004-11/2006 Quality Systems Manager N G Instruments Warsaw,
IN.
Cutting tool manufacturer for the Medical Device Industry
* Report to President in a facility of 75employees.
* Responsible for all daily QA functions, restructuring of QA department, Regula
tory Department,SCARs, CAPAs, MRB and training.
* Written procedures and programming of Metrology equipment.
* Restructured Quality Department by means of Six Sigma and Lean manufacturing.
Instituted automated inspection.

1983 to 2004 QA Supervisor DePuy Orthopedics Warsaw, IN

$1 Billion division of Johnson & Johnson manufacturing a varied line of Class I
II orthopedic products by casting and CNC machining of titanium and stainless st
eel, poly, and celcon with final sales for general surgery.
* Report to the Plant QA Manager with 16 direct reports in a facility of 1200 em
ployees.
* Responsible for all third shift operations, create work schedules for all thre
e shifts, maintain/manage third shift tool room.
* Provide technical expertise to QA and production personnel.
* Perform audits, corrective actions, inspections, and maintain FDA files.
* Leader of Six Sigma project which reduced inspection time, increased productiv
ity, and saved 100K per year with no financial investment incurred on project.
* Lead internal auditor.
* Perform root cause and failure analyses on any returned product.
* Promoted from CNC Team Leader in 1998.
* In charge of clean room and sterilization quality, i.e.; bio burden count, par
ticle count, and verification of gamma sterility.
EDUCATION
Canterbury University (2001-2002) BS Business Administration OnLine
IPFW Fort Wayne, IN (1965-1969)
Additional Training
Six Sigma Green Belt Johnson & Johnson 2002
Auditor Certification Johnson & Johnson 2001
Proficient in Minitab Statistical Software, AS400, Gagepack EZ 7.5, Excel, Word,
Power Point, and Publisher.
80 hrs Business Mngmt Training J&J 2000-2004
20 hrs Leadership Training Exactech 2004-2005
References furnished upon request.