Close
Overlay

Mark Nemitz - Florida

Mark Nemitz
Send Message
Connect

About Mark Nemitz

Mark+Nemitz
Mark Nemitz is currently living in Florida, and is interested in Manufacturing.
Not the person you're looking for?
Find more results for Mark Nemitz

Location

Florida

Categories of Interest

Manufacturing

Resume

Mark B. Nemitz


4110 15th St SW
Lehigh Acres, Fl. 33976
mbnemitz11@juno.com

239-209-4052

Summary of Qualifications
Established Quality / Regulatory professional with extensive senior level
experience in product development skills combined with experience in costs
reductions for manufacturing using the following proven disciplines:

ISO Systems 9001:2000 & 13845 Statistical Process Control
Blueprint Interpretation Classes
Quality System Requirements Sterilization AAMI's 11135 & 11137
510K Accomplished
Process/System Auditing Document Control Systems
CE Mark Acquired
Calibration Systems CARS/ SCARS
GMP's
ASQ Certified Codes of Federal Regulations
Packaging Medical Devices
MDD experienced


WORK EXPERIENCE

Disc Motion Technologies
2000 NW Corporate Blvd
Boca Raton, Fl 33431

Specification Generator for the Truedyne and TrueDisc implant systems.

Director of Quality 10/2006 to Present


. Established and maintained the Quality Assurance Department.
. Established, generated and implemented the company quality manual to
GMP (QSR) as well as ISO.
. Created Master Device Files and Device History Records for medical
devices.
. Outline and implemented the following departments:
. Gage Calibration, Document Control, and Quality Control.
. Generated, specification sheets based on customer criteria, Set-up
inspection routines/procedures.
. Supplier corrective actions.



Future Machine Inc
839 S. Neenah Ave
Sturgeon Bay, WI 54235

Manufacturer of Titanium Bone Screws and Implants for the Medical Industry.

Quality Assurance Regulatory Affairs Manager 2/2005 to 2/2006


ISO Systems 9001:2000 & 13845:2003
. Established and maintained the Quality Assurance Department.
. Established, generated and implemented the company quality manual to
GMP (QSR) as well as ISO.
. Created Master Device Files and Device History Records for medical
devices.
. Outline and implemented the following departments:
. Gage Calibration, Document Control, and Quality Control.
. Generated, specification sheets based on customer criteria, Set-up
inspection routines/procedures.
. First article layout, CMM programmer.







Structure Medical Inc.
2975 South Horseshoe dr.
Naples Fl. 34104

Manufacturer of Titanium Bone Screws and Implants for the Medical Industry.


Quality Assurance Regulatory Affairs Manager 5/2003 to 11/2004

ISO Systems 9001:2000 & 13845
. Established and maintained the Quality Assurance Department.
. Established, generated and implemented the company quality manual to
GMP (QSR) as well as ISO.
. Created Master Device Files and Device History Records for medical
devices.
. Outline and implemented the following departments:
. Gage Calibration, Document Control, and Quality Control.
. Generated, specification sheets based on customer criteria, Set-up
inspection routines/procedures.
. First article layout, CMM programmer.

Arthrex Manufacturing Inc.
2900 South Horseshoe Dr.
Naples, FL. 34104

Manufacturer and packaging of Titanium Bone Screws and Implants for the
Medical Industry.

Quality Assurance & Regulatory Affairs Manager 7/1999 to
4/2003

Packaging Medical Devices
ISO Systems 9001:2000 & 13845
. Established and maintained the Quality Assurance and Regulatory
Affairs departments.
. Fundamental in the successful acquisition of ISO 9002 / 13488
registration.
. Established, generated and implemented the company quality manual to
cGMP (QSR) as well as ISO.
. Created Master Device Files and Device History Records for medical
devices.
. Setup, IQ, OQ &, PQ's for class 10,000-clean room as well as all
policies, procedures and forms.
. Wrote the validation protocol and initiated procedures for the
following:
. (Packaging, Labeling and, Sterilization of Medical Devices). Outline
and implemented the following departments:
. Gage Calibration, Document Control, and Quality Control.
. Generated, specification sheets based on customer criteria, Set-up
inspection routines/procedures.

Contour Medical / Fabricators Inc. 3340 Scherer Dr. St. Petersburg Fl.

Manufacturer and distributor of Sterile Medical Equipment Covers for
Emergency and Operating Rooms.


Quality Assurance & Regulatory Affairs Manager 8/97 to 1999.


510K Accomplished
CE Mark Acquired
Sterilization AAMI's 11135 & 11137
ISO Systems 9001:2000 & 13845
. Established and Managed the Quality Assurance Department.
. Setup Sterilization Services for the sterilization of Disposable
Medical Device's and Kit Trays.
. Proficient in the Medical Device Directives for the CE Mark to
distribute Sterile Medical Devices in the European Theatre.
. FDA Proficient with Code of Federal Regulations Numbers 29 Labor & 21
Food and Drugs. Subpart 820 GMP'S for Medical Devices.
. FDA and EPA compliant for the use of 100% Ethylene Oxide for
Sterilization of Medical Devices
. Wrote and implemented the Protocol for the validation of the 5 pallet
sterilization chamber. Calibration and Gage R&R Knowledgeable.
. 510K's; successfully submitted and received two FDA approvals for
510K's.



laboratory Support Science Professionals
Storz Ophthalmics Inc.

Regulatory & Clinical Affairs Specialist, 08/28/96 to 8/97

MDD experienced

. Provide technical and clinical support to Regulatory Affairs
Department.
. Compliance auditing, clinical monitoring, adverse event reporting
(MDR)
. Review submitted data on investigations of intraocular lenses.
. Maintain investigators' patient study files.
. Communicate with investigators on data related subject matter.
. Analyze returned product complaints and maintain FDA compliance.
. Review in-house information systems to confirm and verify record data.
Constitutional
. Assisted in executing investigators reimbursement for study
participation.


Precise Technology Inc. Plastic Injection Molding Facility

Quality Assurance Technician 7/17/87 to 7/17/96
ISO Systems 9001:2000
. Maintained Quality Assurance Laboratory, ensuring file update.
. Involved with instrumentation and gauge calibration.
. Customer interface / collaborated work with Engineers on new tools.
. Performed first article 100% dimensional layout of new / prototype
tools.
. Made recommendations for engineering / tooling to correct existing
tools.
. Acted as a CMM programmer / wrote inspection routines / programs for
. non-contact inspection with optical coordinate measuring machine.
(OGP).
. Designed various staging fixtures to use for part inspection.
. Generated specification sheets and inspection plans for inspectors

Desired Salary 100K


Education


. Bachelors Degree, Rockville University, Quality Management 2008
. Saint Petersburg College: 1986
. Certificate of Accomplishment in Dimensional Metrology.
. Certified Internal Quality Auditor
. Certified as a Quality Mechanical Inspector.
. Certification as an American Society for Quality Engineer.
. Dale Carnegie Leadership Training for Managers


Professional Societies

American Society for Quality Control member 1987.
Skills:

. Statistical Tools for Process Control. Dr. Juran
. Managing for Continuous Improvement. Dr. Demming
. Computer Literate in MS Office, Lotus, Excel, SQCpack

Quick Profile Summary

Mark Nemitz
Name: Mark Nemitz
Link: http://www.salespider.com/p-5836763/mark-nemitz
Location: Florida,United States

Explore using SaleSpider

Businesses You May Be Interested In

 Business Picture
 Business Picture
 Business Picture
 Business Picture

People you may know from

 Business Picture
 Business Picture
 Business Picture
 Business Picture

Mark Nemitz’s Business Connections

Find more information on the Company

Share This Profile

Member Spotlight

shawna pina Icon
Shawna Pina
Easy Living
Easylivingnow.blogspot.com

Business Spotlight

Designful-Web & multimedia Design Icon
Designful-Web & Multimedia Design
Http://designful.ca/
»
»
»
Mark Nemitz
Who Viewed This Page
458376 views
Last Seen
Thursday August 11, 2016
Top Cities
Delhi 1.7%
Toronto 1.17%
Bangalore 1.1%
Top Browser
Chrome Chrome51.56%
Iphone16.42%
Firefox Firefox14.07%
OS Expand
Windows
42.06%
Android
27.51%
Iphone
16.91%
Device Expand
Desktop
50.37%
Mobile
43.63%
Tablet
5.99%
Language Expand
En-US
64.76%
En-us
17.89%
En-GB
2.84%
spacer pixel