2877 South 8850 West, Magna.

UT 84044

SONY TJUNG Phone: 801 900 7666

Email: Sony.tjung@yahoo.com

Objective
My extensive experience in production, logistic and quality control has prepared me for a more responsible
management position in production or quality control. I have always been detail oriented and now I am ready to
challenge myself for a faster pace environment as a contributing member of your team. Core Competencies include:
• Operations Management • Process Development • Team Leadership • ISO 13485
• Project Management • Verification & Validation • Detail Oriented/Organized • ISO 9001
• Service Oriented • QC Analysis • Self-Motivated/Dedicated • Medical Devices
• Time Management • Product Development • Continuous Improvement • 21 CFR 820
Technical Skills
• Solidworks 2013 • Internet Applications • MS Excel • QuickBook 2013
• Photoshop X4 • Adobe Acrobat Reader • MS Words • Mapic/AS400
• AutoCAD (Novice Skills) • MS Outlook • MS Project • Dynamic Navision
Professional Experience
Bloxr Solutions, LLC – Salt Lake City, UT 2013 to Present
A fast-growing company of radiation protection products for medical and industrial applications. UltraBLOX
attenuating Cream, XPF® apparel technology and BLOXR Shield™ Products.
Manager Production
As the principal behind the startup’s transition from concept to commercial launch, I hired, trained and supervised
all personnel to develop the processes to establish the pilot production. This also included custom production,
testing, and inspection for automated process steps such as Faxitron X-Ray and C-Arm X-Ray testing. My efforts
supported implementation of ISO 13485, ISO 9001 Quality Management System (QMS), 21 CFR 820. I was largely
responsible for the obtaining of a strategic FDA 510(k) clearance, and Canadian Medical Devices Conformity
Assessment System (CMDCAS), managed departmental plans, SOPs, DHRs, MRBs, reports, protocols,
engineering drawings, inventory control, inspection plans, shipment plans including Electronic Export Information
(EEI) filling, Shipper Export Declaration (SED) for international client using FedEx or UPS manager software and
freight LTL/FCL for domestic and international shipment.
Key Accomplishments: Projects I led resulted in a scrap reduction of 40%, cycle time reduction of 50%, Shipping
cost reduction 40% and projected cost savings of $0.2M for 2015. I planned, managed and executed a capacity
expansion, adding equipment, processes and personnel contributing to a revenue of $5M in 2015 and a projected
$10M for 2019.
Amedica US Spine – Salt Lake City, UT 2011 to 2013
Medical device company with an exclusive FDA clearance to manufacture and distribute Silicon Nitride implants- a
patented platform technology for spinal, hip and knee arthroplasty applications.
Quality Control & RMA Specialist
Managed a team that monitored sterilization equipment, sonic washers, biohazard handling and decontamination
of returned surgical instruments. Responsible for conforming to ISO-13485 requirements and passing multiple FDA
audits and ISO re-certifications. Built and worked with efficient teams for self-development, leadership skills, and
problem solving while coordinating with R&D, QA, Marketing and Logistics.
Key Accomplishments: My contributions resulted in plant output doubling through innovative process routing,
resource leveling and productivity improvements. This led to reduced product delivery lead-time reduction of 35%
through organizational changes and rapid turn around as well as an increased output of a critical process.
Medical Component (MedComp) – Salt Lake City, UT 2008 to 2011
Premier developer, manufacturer and supporter of cutting-edge vascular access catheters products.
Assistant Manager Operation
Managed all product safety regulations for compliance while coordinating product delivery under tight constraints.
My supervision produced quality results while maintaining rapid turn-around and increased output in a critical
process. It was my responsibility to monitor finished goods product inspections to meet quality regulation standards
of the FDA. I also ensured that all products were properly identified and conformed to all Quality Management
System (QMS) ISO-13485 requirements.
Key Accomplishments: Under my supervision of 10 warehouse staff, I successfully expanded the warehouse to
accommodate the transfer of all international product from Pennsylvania headquarters to Utah. My contributions
doubled plant output through innovative process routing, resource leveling and productivity improvements
Education
BA Business Administration. International business and economics 1993-1997, University of Pakuan – Indonesia.