AJAZ AHMED ANSARI

***** ******* ****, ******* ** 94536

Phone: 510-***-****, E-mail: acn3zt@r.postjobfree.com

PERSONAL PROFILE

• 10 years of Role in Leadership, Quality Coordination, Inspection, Testing, Validation, Analysis, and Returns.

• Experience with basic mechanical hand tools such as calipers, micrometers, gages, etc and optical comparators.

• Hands on using volt and fluke meters, high pot tester, safety analyzer, microscope, tegam, infrared photo & laser

tachometer, PCB, Cables, Harness testers, chip program, testing, software test & verifications.

• Work efficiently and accurately under little supervision.

• Effective inter-personal communication among different levels of an organization.

• Ability to understand and apply regulatory (QSR, ISO) requirements in everyday activities.

• Good knowledge GD&T, interpreting Engineering Drawing (Blue Prints).

• Computer and ERP software application skills: such Windows, Microsoft Excel, Access, Power Point, File Maker,

Novell Expandable/ MRP, Caileus, Man Man, Sap, Agile, Oracle, Great Plains, Visuals, Arena Solution, Bee –

Pack, Enterprise one JD. Edward Oracle.

PROFESSIONAL EXPERIENCE

Illumina Inc, Hayward, CA September 2013 to December 2013

Senior Incoming Quality Control Tech

• Trained other Quality Technician on new and existing products upon request of quality manager.

• Updated quality inspection visual and automated test procedures, checklist and other documents.

• Inspection of electro- mechanical raw-materials per standard operating procedures, sample plans.

• System Integration of Syringe Pumps, Y-Stages and E-Boxes with Software Applications.

• Inspection of C bot, I scan, Genome Analyzers, Miseq and Hiseq systems per CINS and PINS.

• Performed (TINS) Temporary Inspection on special Proto-Type Projects assigned by quality manager, engineer

and research & development engineers, such as verifying straightness on plastic top cover are within specs and

confirm it fits well with bottom cover, visual and testing of 800 ml waste plastic bottles to verify no pinholes and

passed leak test.

• Accept/ Reject and transact in enterprise one, JDE Oracle, make appropriate disposition to stock or MRB

accordingly, in case of non- conformance, open NCM data base and created a non-conformance report, upon

inspection results, record and retained inspection data hard copy and in the incoming excel daily log.

• Interfaced and communicated with engineering, mfg, purchasing, materials, shipping and other departments.

Covidien SanJose CA October 2011 to July 2013

Senior Incoming Quality Control / Assurance Tech

• Trained Inspectors, other Quality Technician on new and existing products to complete work in timely manner.

• Updated standard operating procedures, dimensional, functional and visual inspection checklists, other forms.

• AQL visual, dimensional, functional incoming inspection of electro - mechanical fabricated and sheet metal,

plastic, PCB, cables, loctites, ointments, compounds, reagents, formulation, etc. parts for manufacturing of

finished medical vascular therapy devices and products.

• Utilized hand tools such as pin, snap gages, ruler and on latest version of vertex 220,330, /440 model micro vu

comparator measuring distance, diameter, thickness concentricity.

• Inspection and testing of catheters and radio frequency generators verifying calibration & thermocouple

temperature are in within plus/minus range. Also visual inspection and testing of Infiltration Pumps at IQA Lab.

• Performed in-process and final inspection of Closure Fast and RFS2 cable.

• First Articles, Audit DHRs, write NCMR, and following CAPA & DR during different stages of my work.

• Responsible for calibration of both mechanical and electrical tools and test equipment, maintain cert’s, records.

• Inspection and Investigation of customer returned products such as verifying complaint, identifying root cause,

notify the customer of the problem and take their approval and once repair completed make sure all the results of

investigation and repair is recorded in the File maker database and close the investigation as completed.

• Work with quality manager, quality engineers, research & development engineers with new products to be

released to manufacturing floor for mass production of the products.

• Interfaced and communicated with engineering, mfg, purchasing, materials, shipping and other departments.

Acclarent, a Johnson and Johnson Company, Menlo Park CA June 2011 to July 2011

Sr. IQC Tech. Electro-Mechanical

• Performing visual inspection and testing of electro- mechanical raw-materials.

• Utilized hand tools such as pin, snap gages, ruler and on latest version of vertex 220 /440 model micro vu

comparator measuring distance, diameter, thickness concentricity.

• Performed in-process and final inspection of illumination systems, inflation devices, balloon dilation systems,

micro- flow spacer guide deployment, also investigation and testing of customer return products.

• Accept and Reject Per AQL sample plan, record and retain inspection results in daily logs, initiated

NCMR’S,CAPA, MRB, process validations, Responsible maintenance and calibration of tools.

Ultra Clean Technology Inc, Hayward CA December 2009 to August 2010

Sr. QC/QA Tech. Electro-Mechanical

• Inspected and measured simple to complex mechanical machined fabricated, sheet metal and plastic parts

• Performed first article inspection.

• Testing and inspection of simple to complex thru hole and surface mount components.

• Performed QA pass / no pass test.

• Per IPC-610 visual inspection of PCB’S for component identification & proper installation, verify polarities,

check solder defects such as cold solder, fractured joints, solder bridges, pin holes, labels with revisions & serial

numbers. Perform Auto pass /fail test.

• In-Process and Final inspection.

• Verify the device records

• Knowledge and understanding of GD&T, ISO, IPC-610, FDA, GMP, sample plans and audits internal/external.

Sanmina Corporation, SanJose, CA July 2009 to November 2009

Sr. Receiving Inspector E / M

• Trained Inspectors, other Quality Technician on new and existing products to complete in timely manner.

• Inspection of incoming raw- materials, both surface mount &thru hole electronics components and sheet metal.

• In-process, final inspection and testing of networking, optical, medical devices, aerospace and semiconductor

systems.

• Make sure device history records are accurate and up to date by verifying in-process and final inspection checklist

and test data. Record and retain all inspection results in the data base.

THORATEC Corporation, Pleasanton, CA January 2009 to February 2009

Sr. QC/QA Tech. Electro – Mechanical

• Supported Manufacturing and Incoming quality control with Inspection of Mechanical & Electrical Parts, metal

fabricated parts, Plastics, Chemicals, compounds and Medical Adhesives.

• Verify complete documents such as P.O. Revs, Procedures, QTY, Approved Suppliers against company’s internal

financial Server, Agile Data base.

• In-Process and Final Inspection of heart mate instrumentation and battery packs per in-process checklist.

• Maintain QA Master and DHR Records. Interfaced and communicated with manufacturing, engineering,

purchasing, customers and suppliers in person and or by completing a material status form through companies

email.

XTENT Inc., Menlo, CA March 2008 to April 2008

Sr. QC/QA Tech. Electro – Mechanical

• Independently managed and coordinated inspection on the second shift.

• Dimensional checks utilizing basic mechanical hand tools.

• Visual Inspection of medical eluting drug delivery stent systems and catheters per in-process checklist.

• Performed final inspection testing.

ACCURAY Inc., Sunnyvale, CA July 2006 to July 2007

Sr. QA/QC Inspector, Electrical / Mechanical

• Performed incoming inspection on mechanical fabricated parts, sheet metal enclosures, chassis and plastics.

• Performed first articles & source inspection.

• In- Process Inspection of radio frequency imaging systems per in-process checklist.

• Final Inspection & testing of cyber knife imaging systems verifying it functions as required and intended per final

QA procedures & checklist.

• Prepare SPC charts, weekly and monthly status reports for management.

• Coordinated Incoming, In-process, Final and Shipping Inspection.

ARTHROCARE Corporation, Sunnyvale, CA October 2005 to June 2006

Sr. QA / QC Inspector, Manufacturing and Research & Development

• Provided support to quality, research and development and manufacturing engineers on projects.

• Inspection of prototype mechanical fabricated parts for medical product.

• In-Process visual inspection of medical oblation & other devices verifying all assemblies & subassemblies

installed properly and all hardware tight & secured.

• Final inspection & testing of oblation devices confirming the device functions as intended per final QA.

Credence Systems Corporation, Milpitas, California April 2004 to January 2005

Lead QC / QA Tech

• Supervised, trained and motivated three quality technicians in accordance with credence drawings, manufacturing

and quality inspection instructions.

• Coordinated duties at incoming, in-process, final and customer return inspection.

• Performed visual, dimensional and testing of electro-mechanical parts.

• First Articles, Source Inspection, Internal and External Audits.

• In-Process, final, customer return inspection of automated testing equipments for semiconductor company.

• Accepted and Rejected parts, depending on results moved parts to stock or MRB, record inspection results in SAP

database.

• Wrote and revised procedures, check list, prepare SPC charts, weekly, monthly reports for management.

Robbins Scientific Corporation, Sunnyvale California May 2001 to May 2003

Lead QC / QA Inspector

• Supervised, trained and motivated two quality inspectors in accordance with RSC Sop, QSR, drawings.

• Coordinated duties incoming, in-process, final, customer return inspection.

• Performed visual, dimensional and testing of electro-mechanical parts.

• First Articles, Source Inspection, Internal and External Audits.

• In-Process, Final, Customer Returns Inspection of Incubators, Micro-Heating & Lab diagnostic systems.

• Accepted and Rejected parts, depending on results moved parts to stock or MRB, record inspection results in

ERP System such as Microsoft Caules.

• Wrote and revised procedures, prepare check list, SPC charts, weekly, monthly reports for management.

• Responsible for calibration of tools & equipment, maintain serial logs, certificate of calibration.

• Work and interacted as liaison between manufacturing, purchasing, suppliers and customers.

EDUCATION:

• Certificate of Completion in G.M.P. Compliance, Quality System Regulation, Handling FDA Inspections.(2013)

• Certificate of Completion in Business Supervisory Management, De Anza College, Cupertino, CA (2000-2002)

• Certificate of Completion in Electro - Mechanical Assembly & Inspection, San Jose Regional Vocational Center,

San Jose, CA (1980-1980)

• Completion of Courses in Quality Assurance & Principle Electronics Testing, De Anza College, CA (1981)

• Studied Economics and Commerce, St. Joseph’s College, India (1973 – 1976)

• R.B.A.N.M.’S High School BLR. India. 1969 -1973

Reference: Available upon request.

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