GQSI provides special process services and engineering for OEM and tier 1 suppliers in industries such as medical devices, biotechnology, pharmaceuticals, and aviation. Services include laser marking, inspection and packaging, cleaning and passivation, and validation and engineering. GQSI is ISO and FDA certified and has over 20 years of experience supporting suppliers.

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