ThanhVan Mai

408-***-**** ad3q4z@r.postjobfree.com

OBJECTIVE:

Looking for a challenging position where I can utilize and further develop my operations skills as a key contributor to product development or commercial manufacturing organization.

SUMMARY of QUALIFICATION:

Over 18 years of experience in medical device industry and additional 6 years in electronic systems integration company. Relevant experiences include execution of engineering studies, medical device quality control, testing and inspection according to manufacturing process documents and quality inspection procedures.

SKILLS:

●High attention to details; orderly and thorough data collection

●Trained to follow Good Manufacturing Practices (GMP), ISO 13485:2016, ISO 9001:2008, FDA 21 CFR 820

●Detail-oriented, self-motivated team player, and capable of training other associates

●Ability to quickly learn new tasks, use of machinery, and tools with minimal supervision.

●Worked closely with process engineers and independently executed R&D engineering study protocols for evaluation of new process technologies.

●Used Instron (5943) digital micrometer, Instron, Vision System, Laser Micrometer, Digital Multi Meter (DMM), Drop gage, Optical comparator, Olympus, Calipers, Snap gage, Go/NoGo, Weight scales and more.

●Software: Word, Excel, Power Point, Outlook, Visual Basic 5.0, SQL, Server, OS, Access, and MS-Exchange

●Hardware: Micro base Information System, DC, AC Circuit, System Design I and Analysis

●Proficient in print circuit board and electrical sub-component troubleshooting

PROFESSIONAL EXPERIENCE:

Imperative Care Inc. Sr. Quality Technician 01-2020-Present

●Line audit

●Created (NCR) nonconformance report and followed process when disposition completed.

●Reviewed and released FG device history records (LHR) and quality-related documents for accuracy and completeness.

●Provided support to Research & Development (R&D) with new products and new design testing.

●Reviewed documents: Labels, Procedures, Engineer builds, and Drawings. High attention to detail.

●Documented inspection results by completing reports and logs.

●Performed destructive product testing using Instron, Laser Mic and Vision System.

●Recorded and retained inspection results- Quality Inspection Dimensions per Acceptable Quality Limit (AQL). Assigned equipment numbers and maintained equipment calibration logs.

●Supported packaging inspection prior to shipping.

Gener 8 Sr. Quality Specialist Technician 07/201*-**-****

●Reviewed and released device history records (DHR) and quality-related documents for accuracy and completeness.

●Used QAD to transfer parts from IQC to stock or other area control of materials are possible.

●Logged/tracked materials from receiving inspection process including recording transactions.

●Provided incoming materials inspection, first article (FAI), in-process, FG, and lab equipment inspections.

●Created (NCR) nonconformance report and followed process when disposition completed.

AirXpanders, Inc. San Jose CA Sr. Quality Assurance Technician 05/2017-08/2019

●Reviewed and released device history records (DHR) and quality-related documents for accuracy and completeness.

●Used QAD to transfer parts from IQC to stock or other area control of materials are possible.

●Reviewed and dispositioned for Return Material Authorization (RMA).

●Assigned equipment numbers and maintained equipment calibration log.

●Assisted with IQ / PQ during manufacturing transfer and new product process validation.

●Provided support to Research & Development (R&D) with new products and new design testing.

●Logged/tracked materials from receiving inspection process including recording transactions.

●Recorded and retained inspection results- Quality Inspection Dimensions per Acceptable Quality Limit (AQL).

●Reviewed and approved sterilization records and reports.

●Provided incoming materials inspection, first article (FAI), in-process, FG, and lab equipment inspections.

●Reviewed suppliers’ Certification of Compliance, Certification of Analysis.

●Created (NCR) nonconformance report and followed process when disposition completed.

●Reviewed documents: Labels, Procedures, Engineer builds, and Drawings. High attention to detail.

●Documented inspection results by completing reports and logs.

●Performed destructive product testing using Optical Comparator and accessory products prior to release.

●Performed functional testing PC Board and Antenna from incoming material inspection.

●Assisted supervisor on special assigned and departmental job requests.

●Supported packaging inspection prior to shipping.

Proteus Digital Health, Hayward CA Quality Control Test Technician 09/2016-05/2017

●Performed and set up Distek Dissolution for testing IEM (Ingestible Event Marker devices), MIT (Mini-in Tablet devices), OE, Digimed, Stability, R&D and more.

●Reviewed DHR and batch records prior to final product release.

●Built, repaired, and inspected DPSS Nd:YAG Lasers from 193-1064nm using high-voltage power supplies. Verified outgoing quality of laser software/hardware and documented deviations and procedural improvements.

●Provided feedback to manufacturing and design engineers to improve product reliability.

●Performed test station setup and connected Ethernet cable from the Hub to the ITS Cartridges with test solution condition using the connectivity test.

●Created new lots and reviewed QC test result.

●Monitored cleanroom for pressure, temperature, and humidity.

●Performed and setup ID Tool (Alto Punch Set Installation), Operator troubleshooting and Alignment.

Calibra Medical Inc., Redwood City CA. Production Lead/QC Inspection 02/2012-09/16

●Performed and reviewed verification, validation, and first article product builds at contract manufacturing facilities

●Performed incoming, in-process, and final product inspections.

●Provided support to Research & Development (R&D) with new products and new design testing.

●Worked on IQ and OQ

●Experienced multiple Internal and External Audit

●Performed cannula forming including cannula length measurement and inspection.

●Trained and supported final packaging, shipping and receiving.

●Cross trained new employees

●Performed verification of all equipment before daily build

●Inspected Incoming reservoir, multiple raw components and packaging components.

●Worked on needle measurement and final inspection for lot released.

Johnson & Johnson Fremont, CA. QC Inspection/Manufacturing 02/2005- 08/2011

●Selected as a trainer for international Technology Transfer project: helped to train the new QC and manufacturing team in Ireland to start the new medical device production line.

●Worked on IQ/OQ and provided inputs to engineers on process improvements and process design.

●Reports all processes and product non-conformances (NCR).

●Proficient with snap-gauge, microscope, hot-box, proximal/distal seal and pleat/fold machine.

●Performed burst testing of R&D catheters.

●Assisted R&D build catheter for new project.

●Followed MPI to perform in-process inspection and final inspection for Balloon Catheter such as Hypotupe, Label Bonding, Balloon Marker Band, Balloon Bonding, Tipping &Transition Fillets, Leak Test and Final Inspection

●Performed testing and measuring dimension and balloon functional testing from incoming material inspection.

●Performed and documented frequent quality inspections, trained line personnel on quality specifications for successful lot release.

●Completed paperwork and provided electronic input to document critical production tasks, including documentation for cleaning procedures, aseptic processing techniques, and other Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.

●Reviewed of in process and finished product traveler and other QC documents.

●Provided feedback and contributed ideas and suggestions to new and /or improved lab techniques, protocols, processes, and special handling of the product and equipment.

●Executed DOEs, validation builds, and engineering test protocols per GDP standards.

●Extensive experience in a regulated (FDA) environment for the product and process development for medical devices. This includes production for clinical studies, first-in-human and commercial products.

●Comfortable with advanced technology: helped develop and operate computer vision, motion control and micro-fluidic drug delivery (piezo jets used to deposit 0.1nl drops at 3000 drops/sec)

●Performed reconciliation of batch records for pilot production and clinical lots

EDUCATION:

Cal State University East Bay, CA. BS Degree of Computer Information System. 2001

Foothill College, Palo Alto, CA. AS Degree in Electronic Technology. 1999

REFERENCES:

Available upon request

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