Engineer Quality

M. JAWAID. IDREES

** *** **** **** ****** Ca. ***66

Home: 909-***-**** Cell: 909-***-****

Email: ********@***.***

OBJECTIVE

To utilize my technical and interpersonal skill as a Manufacturing /Validation/ Supplier/Quality Engineer, where I can increase product quality, profitability, and customer satisfaction toward enhancing company visibility

SUMMARY

Over 15 years of experience in Medical Device / Semiconductor / Aerospace/Avionics as a Manufacturing /Validation/ Supplier/Quality Engineer, which includes the following

Prepared validation protocols including TMV, IMV, as well as IQ, OQ, PQ and PPQ.

Improved the manufacturing processes and reduced waste by implementation of value stream

Knowledgeable/Experience in PPAP, SPC, GD&T, Process control plan, Design of Experiment, Layout inspection techniques, Lean Manufacturing, Gage R&R, DMI/DFA, PFMEA, CAPA, Capability study, Process flow diagrams, root cause analysis, corrective action, value stream mapping and basic laser weld and ultrasonic welding processes.

Continuous improvement by using lean Manufacturing increasing efficiency utilizing ISO 2001; ISO 13485 & CFR820 guidelines

Validation protocols for new product and provide technical support to manufacturing for atrial fibrillation (Catheter Products)

Implemented of ESD on all work stations and write the ESD Procedure according to the need and trained the operator Prepared

Provided customer on-site technical support/services as required. Performed Supplier’s quality process audit and help supplier in cost and scrap reduction. Monitored, Analyzed and Generated Non Confirming Material (NCR) disposition and closure.

Performed source inspection and manufacturing process audits at vendor facilities.

Find Root cause analysis on technical issues reported by customer.

Experience with basic component engineering including, part parameters, specifications and revision control of specification. Responsible for ECR/ECO Initiation, Execution and Closeout, updating of documentation, ERP / MPR changes, material disposition and training of personal and/or CMs

EDUCATION:

West Coast University, Los Angeles, CA

BS Electrical Engineering

California State university- MBA- Courses completed including Engineering management/Manufacturing and Production.

Certified 6 Sigma Green Belt (Teledyne Controls)

PROFESSIONAL EXPERIENCE

. EMI, Santa Ana, CA (Contract) 01/2018 to Present

Manufacturing / Validation Engineer

Responsible for Surface Mount Technology, manual insert component / parts of the bare board, solder, inspection, complete top level,PCBA or bard board and moving to the next level of operation / manufacturing..

Responsible for implementation and generation of work instructions or Flow Chart from Bill of Materials, Assembly drawing or Build package and can understand detailed instructions with minimal supervision.

Communicating manufacturing issues to top level management such as Program Management, Production and Customer.

. Easy Dial, Irvine CA (Contract) 04/2017 to 010/2017

Manufacturing / Validation Engineer

New Product Introduction (NPI) and authoring/execution of validation protocols.

Created and maintained Drawings, BOMS and Documents for the existing and new products.

Ensured new product launched to manufacturing floor smoothly to meet customer requirements.

Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Managed product testing against approved protocols.

Edwards Lifesciences, Irvine CA. 07/2015 to 08/2017

Manufacturing / Validation Engineer (Contract)

Prepared pilot and validation report, as well as BOMs, component drawings and manufacturing procedures

New Product Introduction (NPI) and authoring/execution of validation protocols. Provided technical support to technicians for atrial fibrillation (Catheter Products)

Created and maintained Drawings, BOMS and Documents for the existing and new products.

Ensured new product launched to manufacturing floor smoothly to meet customer requirements.

Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Managed product testing against approved protocols.

Developed and revised standard operating procedures (SOPs). Assisted with equipment selection and specification. Coordinated the approval of quality plans and protocols. Tested and troubleshot various electronic circuits & equipment malfunctions. Provided technical support to technicians for atrial fibrillation (Catheter Products)

Implemented and supported leans activities on the manufacturing floor.

Supported daily manufacturing and daily operations to meet customer requirements.

Monitored equipment downtime and implemented corrective action procedures.

Interfaced with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, FDA regulations.

Improved product and process design by writing engineering change notifications (ECN, ECR & CAPA).

Knowledgeable/Experience in, Design of experiment, Lean Manufacturing, 6 sigma,5S,Gage R&R, DMI/DFA, PFMEA,CAPA, Capability study, Process flow diagrams, root cause analysis, value stream mapping,

Maintained calibration and NCR record for internal and ISO audits

Assisted in establishing suppliers, auditing supplier quality, and monitoring supplier quality metrics.

Reviewed supplier material disposition status and monitor corrective actions from the supplier.

Worked with Supply Chain to review

ST. Jude Medical Irvine, CA. 09/2012 to 07/2015

Sr. Manufacturing / Quality Engineer (Contract)

Reviewed and develop manufacturing documents (MP, Routers, BOM, etc.)

Drafted and executed validation of product, equipment and processes.

Interfaced with other departments to solve production problems. Provided technical support to technicians for atrial fibrillation (Catheter Products)

Prepared pilot and validation report, as well as BOMs, component drawings and manufacturing procedures

Managed required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues.

Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Developed and revised standard operating procedures (SOPs). Assisted with equipment selection and specification. Coordinated the approval of quality plans and protocols. Tested and troubleshot various electronic circuits & equipment malfunctions. Provided technical support to technicians for atrial fibrillation (Catheter Products)

Improved product and process design by writing engineering change notifications (ECN, ECO & CAPA).

Maintained calibration and NCR record for internal and ISO audits

RFA (Request for Analysis): when any complain related with manufacturing and its need to be further investigation for root causes to provided information to Manufacturing Engineering of the floor and RnD department

BIOSENSE WEBSTER (JOHNSON&JOHNSON IRWINDALE, CA. 05/2010 to 4/2012

Validation Engineer / Manufacturing Engineer (Contract)

Prepared pilot and validation report, validated BOMs, drawings and procedures.

Collected equipment calibration data, test results validation protocol development, Cpk, Cp, SPC, hard agaging applications, for laboratories, research and manufacturing environments in the medical device industry, polymer extrusion catheter products. Troubleshoot problems with production and take corrective action. Researched the purchase of equipment and implemented upgrades to existing equipment. Analyzed and improved manufacturing methods in mass production.

Interfaced with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, FDA regulations.

Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Developed and revised standard operating procedures (SOPs). Coordinated the approval of quality plans and protocols.

Improved product design by writing Engineering Change Notifications (ECN, ECO & CAPA).

Maintained calibration and NCR records for internal and ISO audits.

Assisted quality engineering with process improvements and quality audits.

Monitored, Analyzed and Generated Non Confirming Material (NCR) disposition and closure.

Performed source inspection and manufacturing process audits at vendor facilities.

GRIFOLS INC. VALLEY BLVD, LOS ANGELES, CA 10/2009 to 4/2010

Product Engineer

Planned, managed, and documented projects involving the Misterium (Mini Sterile Modular Room) and associate clean room utility systems. Proposed and implemented upgrade projects for existing manufacturing and utility systems. Interfaced with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and FDA regulations.

In depth knowledge of pharmaceutical clean room systems, mechanical systems including HVAC ( heating ventilation air conditioning) and refrigeration systems.

Reviewed projects for compliance with standards from: USP chapter <797>, FDA & ADA, OSHA, and GMP Guidelines for manufacturing.

THALES AVIONICS INC. IRVINE, CA. 02/2006 to 8/2009

Sr. Product Engineer /Manufacturing Engineer

AVIZA TECH INC /ASML THERMAL DIVISION, Scotts Valley/Orange, CA 05/1993 to 1/2006

Sr. Manufacturing Engineer/Field Service Engineer

SKILLS, TRAINING AND ACHEIVEMENTS

• Microsoft Office (Power Point, Excel, Word), Mini Tab

• Solaris Sun Working in UNIX, Oracle applications

• AutoCAD / Visio, Lab View, Minitab, Mat Lab, FORTRAN, BASIC & SPICE

• Frequency generators, Oscilloscopes, DVM, Analyzers and meters

• Member of Failure Review Board (FRB), MRB and FRACAS teams.

• Certified Six Sigma Specialists. Certified in ESD, Electrical Safety and Clean Room Practices

• Certified of Lean, 5S and Kaizen team. Identify opportunities to improve Electrical Manufacturing

Engineering. Practices and implement as required

AFFILIATIONS AND INTERESTS

American Society of Electrical Engineers (ASEE)

PERSONAL

Citizenship: USA

Dedicated, Team player, trust worthy, diversified and global vision.

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