Quality Inspector
Resume:
Fremont CA
Email: ************@*****.***
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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