1. GQSI SPECIAL PROCESS
SERVICES AND ENGINEERING
OEM & TIER 1 SUPPLIER PRODUCT SERVICE SUPPORT
LASER MARKING – UDI AND TRADITIONAL LASER
MARKING
INSPECTION AND PACKAGING – STERILE (CER)
AND NON-STERILE LABELING AND PACKAGING
CLEANING AND PASSIVATION
INDUSTRIES
MEDICAL DEVICE
BIOTECHNOLOGY
PHARMACEUTICAL
CLINICAL
AVIATION
AUTOMOTIVE
MILITARY AND GOVERNMENT
ISO 13485 AND 9001 CERTIFIED
NMSDC CERTIFIED MINORITY BUSINESS
WOMAN OWNED BUSINESS
□ 3777 WINCHESTER □ MEMPHIS, TN 38118 □ 901.365.9570 □ WEBSITE: WWW.GQSI.NET
2. COMPANY OVERVIEW
CORPORATE PROFILE
GQSI is totally committed to OEM and Supplier
Quality Excellence with an unprecedented “VISION
OF TOTAL QUALITY”. Our staff of seasoned Quality,
Manufacturing, Engineers, Operations, Laser Marking,
Packaging, and Cleaning and Passivation personnel
are here to provide OEM and Tier 1 Supplier Product
Service Support with a company philosophy that is
apparent throughout our entire operation that “WE
HELP MAKE GOOD THINGS BETTER”
VALUE PROPOSITION
A VENDOR WHO CAN GET THE JOB DONE
20+ years of deep, specialized experience setting up and validating
processes from an empty shell “Green Field” for over 50 suppliers
Known and respected in the medical device industry for
process/quality improvement
An approved OEM, Tier 1, and Tier 2 medical device Supplier with a
proven track record
FINANCIAL SAVINGS
OEMs and Suppliers can avoid capital outlays for
equipment/facilities/personnel associated with special processes
HELPS OEM’s ACHIEVE MINORITY PARTICIPATION
GOALS
MISSION STATEMENT
We are dedicated to providing 100% customer
satisfaction, while maintaining our total commitment
to Quality. We are commitment to ensuring that our
facility maintains the State of the Art Equipment, as
well as, the latest training and technology available
for our processes.
SERVICES
QUALITY MANAGEMENT SYSTEM (QMS)
SAP ERP/EDI PRODUCTION AND ACCOUNTING SOFTWARE
SYSTEM
TWO (2) SHIFT PRODUCTION
FULLY VALIDATED SYSTEM
STANDARDIZED PROCESSES
ERROR PROOF PROCESSES
JUST IN TIME (JIT) PRODUCTION
EXPEDITED SERVICES
□ 3777 WINCHESTER □ MEMPHIS, TN 38118 □ 901.365.9570 □ WEBSITE: WWW.GQSI.NET
3. LASER MARKING SERVICES
- FDA UDI AND TRADITIONAL
SERVICES
STATE OF THE ART FOBA M2000 AND M3000
SERIES LASER MARKING INTELLIGENT MARK
POSITION VISION SYSTEM
UDI GS1 BARCODE IN LINEAR, HUMAN
READABLE, AND 2D MARKING CAPABILITIES
COMPLIANT WITH 21CFR201.45
FIELD INVENTORY REWORK
FDA UDI COMPLIANT DIRECT PART
MARKING (DPM):
OEM CURRENT PRODUCTION
TIER 1 SUPPLIER
MATERIALS:
METALS – 17-4 SS, 300 SERIES SS, 400 SERIES SS,
TITANIUM, ALUMINUM, COBALT CHROME
PLASTICS – POM-C, POM, H, PPSU, PEEK,
PMMA, POLYPROPYLENE, PTFE, ABS,
POBLYCARONATE
MEDICAL DEVICE INDUSTRY – IMPLANTS,
NON-IMPLANTS AND INSTRUMENTS
AUTOMOTIVE – INTERIOR TRIM, EXTERIOR
ORNAMENTATION
AEROSPACE – INTERIOR
□ 3777 WINCHESTER □ MEMPHIS, TN 38118 □ 901.365.9570 □ WEBSITE: WWW.GQSI.NET
FDA UDI COMPLIANT
4. STERILE AND NON STERILE
PACKAGING SERVICES
SERVICES
STATE OF THE ART BELCO STC2016 AND
STC 2520 SEALERS AND TUNNELS
STERILE AND NON-STERILE PACKAGING
CLEAN ROOM (CER) – CLASS 8
ENVIRONMENT
UDI AND TRADITIONAL LABEL AND
PACKAGING SERVICES
GS1 BARCODE IN LINEAR FORM
GS1 BARCODE IN 2D DATA-MATRIX FORMAT
POUCH SEALING
LABELING
DISTRIBUTION SERVICES
FDA UDI COMPLIANT LABELS
OEM CURRENT PRODUCTION
TIER 1 SUPPLIER
MEDICAL DEVICE INDUSTRY – IMPLANTS,
NON-IMPLANTS AND INSTRUMENTS
□ 3777 WINCHESTER □ MEMPHIS, TN 38118 □ 901.365.9570 □ WEBSITE: WWW.GQSI.NET
FDA UDI COMPLIANT
5. CLEANING AND
PASSIVATION SERVICES
SERVICES
STATE OF THE ART ESMA E992 AUTOMATED
PASSIVATION SYSTEM
100% AUTOMATED SYSTEM
ULTRASONIC WASHER, CITRIC TANK,
CITRIC/NITRIC TANK, ALKALINE (BASE) TANK AND
TWO (2) DI HOT WATER RINSE TANKS
HMI CONTROLS
pH AND CONDUCTIVITY MONITORS
ANDON LIGHTING
OEM CURRENT PRODUCTION
TIER 1 SUPPLIER
TIER 2 SUPPLIERS
MEDICAL DEVICE INDUSTRY – IMPLANTS, NON-
IMPLANTS AND INSTRUMENTS
AUTOMOTIVE – CHASSIS AND POWERTRAIN
AEROSPACE – FASTENERS AND SEALS
MILITARY AND GOVERNMENT – FASTENERS AND
SEALS
□ 3777 WINCHESTER □ MEMPHIS, TN 38118 □ 901.365.9570 □ WEBSITE: WWW.GQSI.NET
6. VALIDATION AND
ENGINEERING SERVICES
SERVICES
IQ, OQ, AND PQ
PRODUCT, EQUIPMENT, AND PROCESS
VALIDATION
MACHINING VALIDATION– MILLS, LATHES,
EDM’S, AND ANCILLARY EQUIPMENT
SPECIAL PROCESSES VALIDATION – HEAT
TREAT, CMM, LASER, CITRIC AND NITRIC
PASSIVATION
FACILITIES VALIDATION – COMPRESSORS,
HVAC, RO SYSTEMS, BOILERS
FREEZERS, COOLERS, AND STORAGE
CONTAINERS
CLEANING VALIDATIONS
TEMPERATURE MAPPING
CLEAN ROOM VALIDATION
ANALYZE VALIDATION DATA, INVESTIGATE
FAILURES AND CAPA’s
MULTI-FACILITIES VALIDATION
PRODUCTS:
MEDICAL AND BIOMEDICAL EQUIPMENT,
INSTURMENTS, AND DEVICES INCLUDING
BIOLOGICAL HUMAN AND NON-HUMAN
TISSUE
□ 3777 WINCHESTER □ MEMPHIS, TN 38118 □ 901.365.9570 □ WEBSITE: WWW.GQSI.NET