Customer Service Quality Assurance
Resume:
Alex Luloh
*********@*****.*** • *** SE Westminster Place, Stuart, FL 34997• 772-***-****
Objectives
To obtain a long lasting position in the field of quality assurance, so as to assist in the development and
maintenance of company procedures, policies, employee training & management in a step towards
compliance with U.S. and international regulations. Maintain professionalism and a vested interest with my
employer, in an effort to achieve product and market excellence.
Work Experience
dp Distribution & Consulting, Inc.
7305 Hancock Village Drive Suite 109, Chesterfield, VA 23832
Independent Regulatory Consultant March, 2013 – Current
Investigate company’s needs in order to deliver value added regulatory advice based on their size
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and marketplace requirements.
Design and delivery of custom fitted quality system procedures, activity protocols, 510(k) & CE
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mark submissions, technical specifications and various other regulatory needs.
Provide both on site and remotely hosted corporate training on subjects such as quality system
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implementation, inspection processes, process validation and risk assessment scaled to the user’s
needs.
Anemathis Armory, LLC.
• 944 SE Westminster Place, Stuart, FL 34997
Owner/Operator November, 2012 – Current (Inactive)
Home based. Type 02/03 SOT, FFL Holder.
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Design of firearm silencers/suppressors and muzzle devices.
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Online resale of small arms and collectible antique firearms.
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Alex Luloh
• • •
Insight Instruments, Inc.
2580 SE Willoughby Blvd., Stuart, FL 34994
Director of Quality & Regulatory Affairs June, 2009 – March, 2014
Establishment and implementation system procedures and protocols which promote efficiency and
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ensure compliance with FDA and Canadian medical device regulations as well as international
ISO:9000/9001 and 13485 requirements. Including such subjects as sterilization, standardized
testing, 510(k), CE marking, process, validation, document control, design control, vendor
management, inspections, risk analysis corrective & preventative actions (CAPA), among others.
Design and management of electronic document control system, review and implementation of
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official quality system changes including but not limited to: system procedures, CAD drawings,
work instructions, training records, material inspection criteria, advertising campaigns (compliance)
…
Oversight of product and material inspection processes, establishment of inspection criteria,
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handling/disposition of non conforming product, release of final product.
Design and oversight of customer complaints procedures, training of employees in appropriate data
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collection and evaluation/correction of potential or actual hazardous product situations where
necessary.
Hosting and scheduling of FDA, ISO and Internal regulatory inspections, including implementation
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of necessary correction and corrective action plans and risk analysis.
Attend bi weekly and scheduled executive meetings to cover such topics as sales/marketing,
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manufacture, and product design in order to apply regulatory guidance to management personnel.
Implementation and organization of multiple large scale product recalls due to changes in European
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Union regulatory viewpoints, as well as development of product reprocessing plans to minimize
company losses.
Insisted on attending sales/marketing industry trade shows regularly in an effort to become ever
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more familiar with the company competitors, their products, and processes to assure we stay in the
top of our field.
Also responsible for maintaining company network infrastructure, administration of server
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activities, telephone operations, SQL database management, and website form generation.
Alex Luloh
• • •
Surgpro, LLC
• 27034 Fordham Dr., Tampa, FL 33544
Shipping Manager May, 2007 – August, 2008
Order taking and entry, sales order review, order picking, generation and application of packing
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slips and shipping labels, scheduling of package/pallet pickups.
Insight Instruments, Inc.
• 2580 SE Willoughby Blvd., Stuart, FL 34994
Shipping/Receiving Specialist September, 2002 – May, 2007
Telephone customer service, order taking and entry, management of warehouse inventory and
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tidiness, product/material receipt, purchase order/BOL comparison/verification, order picking,
generation and application of packing slips and shipping labels, scheduling of package/pallet
pickups.
Education
American Academy of Miami
May 2004 High School Diploma
• Graduated Summa Cum Laude with an un weighted 3.94 GPA.
• Maintained full time employment for the majority of High School
Oriel, STAT A MATRIX
Ongoing Regulatory Certifications
• In an effort to stay up to date with current industry viewpoints and changes in regulatory
requirements, I continuously seek additional vocational education/training specific to industry.
• Certifications obtained:
Quality Systems for Medical Devices, FDA QSR & ISO 13485 [9/16/13]
o
Design Control Concepts & Implementation [8/19/13]
o
Risk Management & Analysis for Medical Devices [8/12/13]
o
CE Marking, EU Directives, and Guidance Documents [6/6/12]
o
510(k) Process for Medical Devices [6/4/12]
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Alex Luloh
• • •
Process Validation Principles & Protocols [4/2/12]
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FDA Medical Device Quality System Regulation [8/8/11]
o
Quality Systems for Medical Devices, FDA QSR & ISO 13485 [3/16/10]
o
Additional Certifications:
Toyota Corporation, Electric/Hydraulic Forklift Operation & Safety [May, 2004]
o
Notable Skills
• Manufacturing & Machine Operation/Knowledge: CNC, 3 Axis Mill, Engine Lathe, Jewelers
Lathe, Forklift, Equipment Automation, Swaging/Polishing, Sterile Pouch Sealer, Constant Air
Pressure Systems, Soldering, Custom Thread Tap & Die, Drawing Comprehension & Design
• Inspection Equipment: CMM, Laser/Optical Vision System, Optical Comparator, Burst Tester,
Hydraulic/Electric Pull Tester, Sterile Pouch Sealer, Thread Gauges, Gauge Blocks, Height Gauge,
Hand Tools.
Software Knowlege
Proficiency:
• Microsoft Windows Operating Systems (XP, Vista, Win7, Win8, SBS 2008 and Server 2012)
• Apple Macintosh OSX Operating System
• Fedora Linux Operating System
• SolidWorks 3d CAD Design Software (2010,2012,2013)
• Website programming (HTML4/5, JavaScript)
• Microsoft Office Suite Software 2013 (Word, Excel, PowerPoint, Outlook)
• Microsoft Project 2013
• SQL Database Coding/Usage
Familiarity:
• DBA Next Generation Manufacturing Database Software
• Marketcircle DayLite Database Software for Mac OSX
• Website programming (Flash, PERL)
Alex Luloh
• • •
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