Fremont CA

Email: adk1id@r.postjobfree.com

Objective: To Obtain a position in a medical Device or Electronics company where I can apply my skills and experience with continuous advancement and growth

Summary: Quality Control Technician, Material control with over 5 years of making recognized team contributions within the medical Device industry.

Personal Statement:

I am a hardworking individual, self-motivated, team player who works with minimal supervisions. I am quick leaner with the ability to follow written and verbal instructions. I love learning new things to add to my current skill set. I have a positive attitude and encourage all kinds of feedback. I am dependable and ready to help.

Skills include:

Attention to detail.

Material Control

Ability to read, follow and analyze diagram using symbols and codes (schematic or pictorial)

Ability to perform basic repair on mechanical and electronics equipment

Ability to use basic hand tools and measuring devices

Ability to write SOP/MPI, and excellent GMPs

Education and Training

2 years collage course work toward Engineering

Basic electronics

Extensive Training related to Quality systems quality control/quality assurance, and manufacturing operations

Work experience: Senior Quality Assurance 06/01/2019- Present

Exo Imaging Inc 3600 bridgeway Redwood city

Performed essential inspection and measurement of incomings and product including First article inspection of mechanical (flex, PCBs, and PCBA, and wafers) material inspection of components, subassemblies and materials per drawings and specifications

Functional and in-process testing of components and PCB assemblies

Assured that manufacturing records met manufacturing procedures, assuring completeness

Identified and isolated non-conforming products, recorded discrepancies and generated reports in NCR forms

Documented inspection results organized and maintained inspection records per document procedures. Communicate non-conformance material and process as appropriate.

Performed inspection of silicon- based sensor wafers, components and subassemblies using a microscope

Interfaced with engineers to address non-conformities and determine proper remedies

Reviewed final documentation of finished subassemblies and devices for accuracy, completion and compliance

Wrote material specifications, and Standard Operating Procedure Documents (SOPD)

Participate in material review board (MRB) disposition

Log in Inspection record, PO, packing slip, and drawing into Arena PLM software systems

Tested flex circuit PCB assemblies using manual flying probe fixture

Programmed ICs with firmware updates using a socket fixture and laptop

Carry responsibilities in accordance with the organization’s policies and applicable laws.

Material control

April 2018 – April 2019

Operator/R&D Support/Medical Device Assembler

R&D support and assist in writing Manufacturing Process Introduction (MPI) for New Product releases

Philips April 2018 – April 2019

R&D Support/Medical Device Inspector

R&D support and assist in writing Manufacturing Process Introduction (MPI) for New Product releases

Medical device assembly, research, and development in a clean room environment

Determine errors in processes and work with engineers to resolve compliance issues & Identified work product that did not conform to requirements

Excellent documentation practices, QSR/FDA/ISO 13485/CAPA

Maintain Recording & Tracing rejects causes

Quality Assurance and Incoming/Final Inspection and disposition

Follow written procedures for all assembly tasks & Maintained electronic lot history records for traceability documentation

Final quality control check and packaging of electro-mechanical/medical assemblies for shipment

Ensure Lot History Records (LHR) are filled out completely and accurately

Update procedures to incorporate redlines and changes

Worked on production and prototype heart mitral-clip insertion of medical devices & prototype catheters

Ran tests and experiments for developing catheters

Assembled devices using a microscope, air pressure, razor blade, ruler, tweezers and glue, snap gauge, caliper etc.

Abbot Vascular March 2014 – April 2018

Operator and Quality Inspector

Ensure various project initiatives ran smoothly, provided feedback, and coached team-members

Engaged with Supervisor and Team Leads regarding reporting/administration and tracking performance metric goals

Ensure Quality and Compliance with proper documentation

Electro/mechanical and medical assembly and rework. Intricate assembly tasks using a microscope

Assist engineering in developing manufacturing procedures. Document reviews & updates.

Knowledge of Good Manufacturing Practice (GMP) & Good Documentation Practice (GDP)

Familiar with FDA QSR/cGMP/ ISO 13485 standards

Worked on production and prototype heart mitral-clip insertion medical devices

Support engineering on new product introduction

Maintained electronic lot history records for product tractability

Determine errors in procedures and worked with engineers to resolve compliance issues

Identified work product that did not conform to requirements

Duke Empirical

Medical device Assembler / R&D Technician / quality Inspector November-2013

Medical device assembly, research and development in a clean room environment.

Worked on prototype catheters for hemo-dialysis project.

Ran tests and experiments for developing catheters.

Assembled devices using microscope, air pressure, razor, ruler, tweezers and glue.

Used snap gage to check the OD of the mandrel and calipers to check the ID of the liner.

Inspected and measured metal braid to meet engineer selected specification.

Educations

Ohlone College, Fremont, CA

Associate in Science in Bioengineering

ASQ: Certified Quality Engineer (In Process)

Excellent in Microsoft Office, Excel, PowerPoint, Word, Adobe, Omnify and SAP

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