Quality Control Technician (Medical Devices)

Ha Tran

***** ******* **. ***********, **,C: (***) 951- 5083 ********@*****.***

Professional Summary

● Focused and hardworking who is dedicated to tasks at hand and will exceed with great effort. Perseverance through any conflicts that may arise and is quick to act and execute position with concentration and accuracy. Experience in providing a well work ethic. Working for seven years in the restaurant business to more than 5 years in manufacturing medical devices. Education

High school in Vietnam

Skills

● Medical device experience in the areas of production, quality control, and documentation audit

● Understanding of Engineer Drawings

● Ability to use measuring tools (calipers, micrometer, microscope, gauges)

● Understanding of a clean room environment and manufacturing policies

● Able to work individual and in a team environment Areas of Expertise

Time management Relationship building

Organization

Exceptional interpersonal skills

Bilingual Vietnamese

Quality Check operator

Excellent communication.

Experience

Quality Control Tech 2

SeaSpine - Irvine, CA May 2021 - Present

Performs inspections at various stages of production of the product from raw materials, sub-assemblies and final assemblies to assure quality and conformance to specifications and procedural requirements. • Performs and documents QC inspection activities to assure conformance to specification and procedural requirements • Provides feedback to QA, Operations and R&D on quality issues • Performs special projects as directed

● Performs visual, dimensional, and functional inspections of raw material, components, in-process, and final product based on documented specifications (drawing, procedure, work instructions, etc.)

● Documents QA inspection at receiving, in-process, and testing activities to assure conformance to specifications and procedural requirements

● Perform label inspections

● Audits various manufacturing processes to assure compliance and product segregation

● Initiates non-conformance reports (NCRs) and follows-up to final disposition of nonconforming material

● Review and maintain all inspection documentation

● Transact parts and in-process audits in Oracle

● Performs Supporting incoming, in-process and final inspection. Reviewing supporting data, documentation and generating inspection records. Performing a variety of Quality Assurance related tasks in support of engineering and operations. projects as directed.

Performs in process, final inspection, and test operations to assure quality standards for mechanical parts of workmanship and functional performance.

In Process InspectorChecks parts or tooling dimensions using precision measuring equipment such as; gages, calipers, high gauges,micrometers,etc….review production difficulties that are traceable to newly built or faulty tooling, vendor supplied material and manufacturing production procedures. Refers unusual or unacceptable conditions to Supervisor/QC Inspector Lead or Engineering. Confluent Technology - Laguna Niguel, CA Aug 2019 - April 2021

● Perform various types of visual inspections and destructive testing

● Analyze and decide whether to pass or reject product

● Assist the engineering team in order to resolve issues with rejected parts

● Performs types of dimensional inspections

● Familiarizing with inspection tools, microscopes, pin gages, snap gages, etc.

● Inspects OD and ID for catheter

Quality Control Inspector March 2016 - Aug 2019

Edwards Lifesciences - Irvine, CA

● Follow Work Order (W/O) instructions, read drawings, and SOPs to perform visual, dimensional, and functional goods, and devices using a wide variety of tools and equipment to ensure conformance with design specifications

● Inspect Intuity frame

● Perform visual and dimensional inspection components

● Perform Device History Record (DHR) audit per Good Document Practice (GDP) and QA101

● Ensure appropriate documentation was in place to meet Edwards GDP and policies and incorporated approved changes for documentation

● Created, verified and closed Doc-error/ Non-conformance reports in the QMS and JDE

● Good knowledge and understanding of policies, procedures and regulatory guidelines relevant to documentation and cleanroom environment

● Was recognized for Good Performance, Collaboration, Integrity, and Compassion

● Well versed in Good Manufacturing Practices (GMP) clean rooms where also endorse Good Documentation Practices (GDP)

● Effective communication skills both written and verbal Assembler

Applied Medical - Rancho Santa Margarita, CA 2015- Feb 2016

● Silicon injection molding operator

● Clean room Eciion 439, 443 Alexis cap operator

● Clean room Eciion 378, 442 Cone injection molding operator

● Alterman cutting 424, AFM punching cutting, Die cutting operator

● Support for production quality check in sorting and deflashing

● Operator support for daily processing activities on production floor

● Participate training and support in continuous improvement initiatives Assembler

Edwards Lifesciences - Irvine, CA Mar 2016- 2018

● Pericardial Wireform cutting and Preliminary Forming operator

● Automated 3D wire forming operator

● Install Die set operator

Manager Assistant

Bleu Restaurant - Westminster, CA 2008-2015

● Covered finances and trained incoming staff

● Communication with customers

● Schedule and check shipments and food quantities

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