Luong Nguyen ( adwl4p@r.postjobfree.com) 714-***-****

SUMMARY

ASQ: Six Sigma Green Belt Certification. Certified Quality Technician. GD&T strong, ASQ training class Cosmetic Act, 21 CFR Part 820(Quality System regulation) ISO 9001 Additional Skills, GD&T training.

Full understanding of applicable inspection procedures. Ability to continuously expands proficiency in inspection techniques.

Ability to use applicable instruments and equipment, hand eye coordination, and high manual dexterity. Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)

Ability to effectively provide and accept feedback from colleagues on independent data verification. Ability to provide feedback on product defects and follow through to establish resolution.

OTHER SKILLS & TRAINING

Organizational and planning. Problem-solving. Leadership. Industry-specific technical knowledge. Mindfulness. Ability to work as part of a team. Knowledge of quality standards. Time management. Ability to work under pressure (FAI) First Article inspections. Technical skills, understand blueprints, technical documents, and manuals, ensuring that products and parts meet quality standards Operation: Nikon (VMA/VMZ) Keyence IM-7030/7020/ 7010. Smart scope (OGP system) Ram optical, Comparator Optical, and Visual system. Tress test, Pyrogen test, Used Magna mike (8500,8600) Laser micrometer, digital Micro, Digital caliper.

Experience working inside a clean room. Strong analytical and critical thinking skills

WORK EXPERIENCE

EnVVeno Medical- Irvine, 70 Doppler, Irvine, CA 92618

Position: sr QA Tech/ Purchasing, Special released, Warehouse Coordinator (01/15/2021 – 02/25/2022)

Duties: Operation BDC Laboratories Test System: (Hydrodynamic BDC-HDTI-6000. Pressure Monitoring System) BDC-VDT- 3600i (Slop and Offset valves using measurements, the transducer Calibration process. (Support R/D test Frame)

Perform receipt and disposition of incoming apheresis material. Perform verification/inspection and ensure timely issuance of production documents and labels. Perform shipment authorization. Perform incoming label inspection. Review batch-related documentation and ensure resolution of issues to release and ship product. Ensure timely resolution and escalation of issues in operation. Ensure all product-related Deviations are initiated, investigated, and resolved. Vendor management

Ensure that associated CAPAs are initiated and resolved, as needed. Ensure approval and timely delivery of final product. Ensure products are manufactured in compliance with regulatory and GMP guidelines. Ensure products are manufactured in compliance with regulatory and GMP guidelines. Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues. Gather metric information for use in continuous improvement of areas of responsibility. Maintain/Update huddle board tracker, deviation tracking log, task tracker and issue monthly reports. Maintain database of relevant Quality documents to include but not limited to: Supplier Approval documentation, Laboratory Logs, Certificates of Analysis, Sanitation Logs, and Temperature Logs. Accurately interpret lab results, create graphs, and trend data as required. Conduct Facility Self-Audits and assist in employee training of FSQA Programs.

Responsible for ordering products, services, and raw materials for the company or organization. Conducting product research and sourcing new suppliers and vendors.

Sourcing materials, goods, products, and services and negotiating the best or most cost-effective contracts and deals. Performing inventory inspections and reordering supplies and stock as necessary. Conducting market research to keep abreast of emerging trends and business opportunities. Inspecting stock and reporting any faulty items or inconsistencies immediately

Verifies purchase requisitions by comparing items requested to the master list and recommends alternatives. Provides purchasing planning and control information by collecting, analyzing, and summarizing data and trends.

Forwards available inventory items by verifying stock and delivering schedules. Prepares purchase orders by verifying specifications and price, while obtaining recommendations from suppliers. Secures approval from requisitioning department.

Manages purchases by forwarding orders to suppliers and monitoring and expediting orders. Verifies receipt of items by comparing items received to items ordered; resolves shipment errors with suppliers.

Troubleshooting and resolving technical problems in receiving inspection. Provide documentation support and complete written reports on inspections, designs, and component qualification activities. Actively participate in component drawing reviews and provide relevant feedback for teammates. Perform verification of material temperature data and temperature requirements to ensure conformity to data records and time of receipt.

Siegfried - Irvine, 9342 Jeronimo RD, Irvine, CA 92618

Position: QC/QA for Raw Materials Specialist (01/15/2021 – 02/25/2022)

Responsibilities include the management of the day-to-day QC Raw Material documentation, inspection, and sampling. Provide support for Quality Events relating to deviations and CAPA’s. Inspected, review paperwork, took sample for Micro lab strong to follow up all procedure for that there are no contaminations present and that the medications will meet quality requirements and all relevant regulations. Attention to detail and good Documentation practices. Experience with MS Office & enterprise applications (example: Master Control, LIMS, Track wise, etc.)

Primarily responsible for the inspection and sampling of incoming raw materials for consumables and chemicals. Create and update raw material specifications as required. Manage the raw material process to support established timelines associated with the release of material for production use. Manage and maintain all raw material retains and perform annual inspections as needed.

Complete required documentation for the raw material release process in accordance with established procedures. Perform data and documentation review that is associated with investigations and deviations. Create and update raw material specifications as required.

Manage the raw material process to support established timelines associated with the release of material for production use. Create and update raw material specifications as required.

Edwards Life sciences Corp. - 1 Edwards Way, Irvine, CA 92614

Position: Tech, R&D/QA Eng. (01/2020- 12/2020)

Provides technical support to R&D Engineers including input on product design, assembly procedures and product requirements. Assists engineers in developing methods and procedures to control or improve product design processes.

Perform highly diversified duties to develop and run and improve R&D and demonstration equipment. Inspection of raw materials, packaging, in-process, and finished product to defined specifications as per area of responsibility.

Inspected all incoming products, ensuring that all parts and materials conformed to PO requirements, applicable drawing and specifications, trouble-shooting issues on oracle database.

Edwards Life sciences Corp. - 1 Edwards Way, Irvine, CA 92614.

Position: Sr QA Receiving Inspector (10/2016- 01/2020)

Responsible for inspection of receiving raw materials incoming shipments and verifies quantity and other identifying information against the shipping paperwork, and records shortages (NCR if needed). Mechanical inspections, surface Plate, process inspected as detail in router. Ensure correct method, tool and criteria are used for inspections. Support Engineer for CAD (3-D Solid-Modeling) new parts, new fixtures for inspections system. Inspected raw materials, labeling, review all inspections data. Training for new inspector.

Perform visual, dimensional, and functional inspection of components and devices using a wide variety of applicable instruments and equipment such as magnifying lamp, microscope, vision inspection system, calipers, etc. to ensure conformance with design specifications, working at a level greater independence with a higher level of productivity.

Perform verification of receiving documents with component and device drawings to ensure requirements are met.

Review, follow and perform job functions in compliance with established work instructions (i.e., routers) and adherence with SOPs, including recording traceable information on device history records and entering information into JDE.

Control inventory to ensure appropriate storage conditions and movement, as well as ensuring correct labeling of product status.

Train colleagues from other sites, including inspection of their work output.

Other incidental duties: General work area housekeeping, attend training for new processes and procedures.

Freudenberg Medical - 5050 Rivergrade Rd, Baldwin Park, CA 91706

Position: Quality Technician/Lead Receiving Raw Material and Special Release (02/2014- 10/2016)

Lead Receiving, set up receiving inspection, bond area, dimension, report raw material received.

Work with Engineers: CAD/CAM/CAI Computer Aided Design/Computer Aided Manufacturing/ Computer Aided Inspection. The integration of CAD, CAM, and CAI through the common sharing of part geometry definitions and other data jointly used in design, engineering, manufacturing, and inspection.

Generate Material Rejection Report with all non-conforming material and route to Material Review Board (MRB) for disposition, fixed processes, and deviation reports. Customer complaint/Report for critical problem. First article inspection report (FAIR). Improved the sample submission of suppliers by creating a sample tracking spreadsheet to provide accurate testing information and monthly notification to suppliers. Perform thorough examinations of all materials and finished products.

Receives, inspects, and properly documents incoming components, assemblies, and finished good. Maintains proper material labeling and dispositioning in inventory.

Properly maintains and completes operational records, reports, and other required documents.

Tests and manages resulting documentation when needed.

Conduct and report internal audits and evaluations.

Implement and improve quality control operating procedures.

Participate in routine visual inspections.

Maintain a clean and safe work environment.

Wave Tech/Alcon Laboratories - 15800 Alton Pkwy, Irvine, CA 92618

Position: QA inspector/ Sr QA Receiving (RI for Wave tech product) transfer to Alcon employee. (10/2009 through 2/2014)

First article inspection report (FAIR). Receiving raw materials inspection. Nonconformance Report (NCR) Quality Inspection result (QIR). Review Device History Records (DHR) and Quality-Related Documents for Accuracy and Completeness. Dimension of raw incoming Material, component, and Parts prior to their incorporation into Inventory or production.

Knowledge: Equipment for dimension products of Depth Indicator, Digital Caliper, Height Gage, Protractor, Pine Gage, Calibration, O Miss II, OGP (Optical gaging product) Measurement, 3D Quest 450.

Implemented new specification revision procedure that improved the communication and acknowledgements of specification revisions with suppliers.

3M Dental - Irvine, CA

Position: QC Inspector for Receiving Raw Materials/Assembler Production Line (09/2007 - 10/2009)

Product qualification analyzed Documentation Line Clearance form. Approve & Reject products, Finished Goods Using Eli, Lotus 8.5 IBM software and Log sheet method (for back up). Data Record Control Reads blueprints and uses calipers, micrometers, gauges, and other inspection equipment to inspect parts. Ram optical, Micro Vu Excel Multisensory system (Excel 501). Production Line Clearance. Retain sample Retention & Identification (SOP). Hands-on experience for Aligned, joined, and assembled medical components and subassemblies. Examined, tested, and debugged all components and medical assemblies. Detected, managed, and eliminated all assembly-related quality control problems.

Applied Medical - Rancho Santa Margarita, CA 92688

Position: Assembler/Hands-on Production (2/2000 - 8/2007)

Hands-on experience in medical device soldering, creation, and inspection activities.

Build catheters to meet the company sales goals. Meet catheter manufacturing yield and productivity goals. Assist manufacturing/process.

Complete documentation such as Lot History Records per GMP requirements.

Support the introduction of new products onto the manufacturing line.

Follow GMP guidelines. Ability to read and blueprints and technical specifications to produce medical assemblies. Interpreted and followed engineering drawings, work instructions and technical specifications. Assembled medical devices and repaired their faults, in an efficient manner.

Examined and tested components and completed assemblies for conformance to specifications and quality requirements. Prepared and maintained accurate work-related records and test reports. Utilized and maintained all types of tools and machines, properly and efficiently.

Followed established housekeeping standards to clean and maintain workplace.

EDUCATION

Bachelor of Science: Accounting/Business Management - Southern California Attitude of Technology 2008/2012

Certified Quality Technician (ASQ) Training class · Geometric dimensioning and tolerancing (training class by ASQ) – Symmetrix training

ASQ: Six Sigma Green Belt Certification (ASQ)- American Society Quality

CQI/CQT (Certified) American Society Quality Certification (ASQ)

Electrical Safety (Rev1). Blood born Pathogen Certification (Medical Device)

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