Quality Engineer

**** ***** **** ***** ****** TX-***** Res: 972-***-****

Objective: Supplier Quality Engineering position in Customer oriented environment where I can use my six sigma and project management skills to drive down cost.

Qualification:

Highly experienced and result oriented Supplier Quality Engineer with proven track record with over 24 years of experience in all aspects of Quality engineering, product development and manufacturing in regulated industries.

Certified Six Sigma Black Belt and Certified lead auditor for ISO 9000, 17025 and 13485 and CQE.

Demonstrated success in Supplier Quality Management by proactively working with the suppliers using design control methodology by performing Risk analysis. Expertise includes proficiency in developing, implementing, monitoring and enhancing the Supplier Quality Programs and performance metrics. Experience in Supplier Management and Development process i.e. Sourcing/Selection activities and Supplier Audits and Certification, CAPA etc.

Diversified background in Supply Chain Management, Six Sigma, Quality Control/Quality Assurance, Project management, and process improvement, Production and Industrial Engineering. (Automotive, Telecom, Healthcare etc.)

Experience in working with project oriented, diverse and cross-functional team environments.

Team player with strong written and verbal communication and organizational skills.

Experience:

April 07 to present Abbott Diagnostics Irving TX

Sr. Supplier Quality Engineer

Currently supporting the supply chain management’s supplier quality program at Abbott instrument manufacturing plant.

Lead the mechanical group of SQEs for managing supplier control, audit, SCARs , planning, training, budgeting etc.

Responsible for developing, implementing and maintaining the effectiveness of the supplier quality program.

Lead supplier development initiatives and support as technical resource for the materials, operations, quality, R&D and supplier management teams with regards to supplier quality, supplier development and supplier process evaluation.

Scheduled, planned and Lead several dozen supplier audits in the last three years. (Quality system audits & process audits for SCARs). Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers.

Perform process capability analysis and work on improvement of process capability. Analyze data, procedures, and design requirements taking into account financial and business considerations. Make recommendations for options of complex or multiple process and product problems.

Generate and implement improvement plans for driving quality and reduced cycle times for assigned suppliers and improving the quality of underperforming suppliers using Six sigma methodology and other quality tools. Identified opportunities and lead multiple continual improvement projects for supplier quality process improvements.

Developed and implemented a new scorecard system to monitor supplier performance.

Responsible for planning and coordinating for accuracy and on time delivery of supplier score card.

Investigate part non-conformances (CAPA / SCAR) attributed to be the responsibility of the supplier. Issue, resolve and implement supplier corrective and preventive actions. Chair the MRB for the decision regarding parts disposition.

Work closely with sourcing, purchasing, manufacturing and engineering teams to remove roadblocks and improve communications.

Leading the effort for supplier qualification and Process validation through IQ/OQ/PQ. Work closely with divisional/corporate cross-functional teams for supplier improvement programs.

Developed inspection methods and procedures for inspecting, testing, and evaluating of incoming parts from supplier.

Track and trend supplier issues related to part quality, Incoming and manufacturing issues to estimate cost of poor quality.

Facilitated /Lead Six Sigma projects related to supplier improvement and inventory cost reductions.

Report metrics to the management review boards. Supervise, mentor and provide guidance to quality engineers and technicians.

Track key quality metrics and maintain the nonconformance and root cause analysis databases to reduce quality defects in a timely fashion and maintain quality standards.

Initiate and resolve supplier corrective actions (SCAR) through root cause analysis and corrective and preventive actions (CAPA).

Train and coach suppliers on quality systems, regulatory compliance issues (21CFR820) and Abbott quality initiatives.

Aug 06 to April 07 Tyco Electronics Power Systems. Mesquite TX

Supervisor Supplier Quality & Incoming Quality

Supported the NPIA line for Power Systems design. Set-up the entire Incoming Inspection and Supplier Quality system.

Wrote Quality procedures related to the Incoming Inspection. Wrote Inspection plans for the normal and Safety parts using SAP system Quality module. Was responsible for Incoming inspection and First Article Inspection (FAI) for new parts. Participated in the process audit of new suppliers

Managed the MRB. Developed supplier score card system. Worked with Production Managers & Project Managers to identify and resolve quality issues related to suppliers and worked on problem resolution through SCARs.

Nov 99 to Aug 06 Nokia Mobile Phones Inc. Irving TX

June 04 to Aug 06 Care Project Manager:

Worked in the Mobile Phone (matrix organization) Business Group for several GSM programs for R&D.

Managed the Ramp down of products from the after market support point of view.

Audited Nokia repair sites and its sub contractors for conformation to the ISO 9000 and Nokia repair processes.

Facilitated and lead the efforts to establish and monitor customer relations, supported strategic planning and deployment of initiatives.

Facilitated the project team to understand customer concerns and complaints and drive the identification and resolution of product quality issues.

Worked on the problem resolution using Corrective Action tools (Genius). Maintained the quality metrics in order to drive improvements in programs. Involved with and responsible for integrating and coordinating with other programs and functions. This includes coordination with various programs at multiple geographic and feedback into other sites and global functions of R&D CARE.

Identified quality improvement needs and opportunities in R&D, planning improvements and implementing them with R&D teams.

Identified and worked on supplier issues. Was responsible for ensuring an on time feedback to repair centers and providing management with information on the quality of its products and services. Involve peers and networks globally for coordination to achieve this goal, targeted to achieve and maintain customer satisfaction. Was the main quality feedback interface of the project and acted as voice of the customer.

Prepared after Market Service documentation (technical bulletins, work instructions, procedures etc.)

Prepared the monthly Quality status report for Dallas site for feedback to the global management.

Nov 99 to Jun 04. Program Quality Manger:

Supported the TDMA and GSM programs for R&D program quality. Lead the development of IML (In Mold Layer) technology for the phone plastic covers.

Lead the Process audits at various suppliers in Europe, Korea, Mexico and USA for sheet metal, plastics and electrical components. Managed the suppliers for the program support and help the supplier achieve the agreed quality targets. Facilitated early supplier involvement and Design for Manufacturability and Assembly (DFMA).

Headed the program efforts for production line transfer from Nokia Reynosa factory to a supplier in Monterrey (Mexico).

Developed and implemented the Component Quality Plans for several products. Played a major role in the key component approval process. Worked in CE (Concurrent Engineering) process for Nokia product development.

Developed quality plans for various new programs. Made monthly Quality reports including the Best Practice for future programs.

Participated in the supplier selection process and sustained supplier development activities. Initiated early supplier involvement in new product development including prototypes and pre-production. Was also responsible for NPIA quality and yield.

Participated in the implementation of PPAP and APQP as part of the product development process initiative.

Coached and mentored the design engineers in the use of quality tools. Perform QFD (Quality Function Deployment) for early involvement of customers. Performed a number of FMEAs (Failure Modes and Effect Analysis) with the design teams and manufacturing teams for risk analysis purposes. (System, Design, Process and Software FMEAs) Ensure that new concepts are analyzed and risk understood Identify new technology /components.

Design and implement plans for the implementation of latest ISO Quality standards by simplifying the Quality System concepts to understand and implement.

Six Sigma:

Completed several Black Belt projects. These include projects on No service/No Power problem for Woodstock and Reliability lab test requirements, Soft Fail repair process of 8260, reduction of Phase Error in the manufacturing of 3390, the reduction of No Fault Found for 5160 phones. Was able to reduce the NFF for 5160 from 40% down to 25%. In another project for the reduction of Phase Error for the 3390 the Phase Error has been reduced from a high of 6+% to below 1%. Attended the DFSS training.

Oct’98 to Oct99 PMX Industries Inc. Cedar Rapids IA.

Supplier Quality Engineer

PMX is a foundry and a copper re-rolling mill, with US mint as its biggest customer.

Primary function was to execute and oversee the Supplier Quality Assurance program to ensure that the material supplied meet the applicable standards. Managed the material review board (MRB) for material discrepancy and disposition.

Developed and implemented a new scorecard strategy to monitor supplier performance.

Responsible for planning and coordinating for accuracy and on time delivery of supplier score card.

Performed various suppliers’ audits for the quality system and process of critical vendors through written surveys and on site visits. Monitoring the performance of approved suppliers and reporting it back to vendors and higher management. Coordinated efforts with the Purchasing, Engineering, Production and Quality Assurance for qualification of new or replacement materials and services considered critical to quality.

Mar’98 to Oct’98 GNB Technologies: Dallas TX.

Quality Systems Engineer

One of the largest manufacturers of Automotive Batteries in USA. Acted as the company’s ISO representative.

Main responsibility was to Plan and implement the ISO 9001 Quality Systems. This included development of quality control plans and coordinating between all the departments of the company and corporate office in all the quality matters. Control of quality records and coordinate for continuous improvement projects. Implemented different elements of QS 9000, wrote work instructions and procedures for level two & three documentation of QS 9000/ISO 9001.

Responsibilities included making reports for upper management on changes in standards (internally and externally initiated) and on overall company performance against standards, contributed to executive policy and strategy, developed and implemented appropriate evaluation program for new product designs to ensure capability to customer requirements. Helped develop measurement systems to determine organizational improvement Performed a number of internal and suppliers audits including system and process audits.

June ‘96 - to Oct 97 ALLSTYLE MILLS Costa Mesa CA

Shift Manager

One of the largest manufacturers of Fleece & Jersey cloth in USA.

Was responsible for the Production, Quality Control and Maintenance of machines.

Managed over 70 employees, including supervisors for production, maintenance, quality and warehouse.

Planned and supervised Shift, executed work orders and labor grievance handling. Planned and implemented the layout of a new plant consisting of 45 circular Knitting machines. Supervised assembly and installation of this new plant.

Sep‘89 -May’96 HONDA Motors Karachi, Pakistan

Deputy Manager Vendor Developments

Worked in Supply Chain Management of parts. Successfully developed Vendor Qualification programs for production facilities.

Developed supplier delivery process and sourcing process management. Performed production feasibility studies for manufacturing automotive parts, Cost estimation, Process control, Parts development and supplier evaluation and process audits. Participated in the supplier selection process related to new product introduction including prototype, pre-production and production.

Worked on plastic injection molded parts, painting, die-castings, machining, gaskets and sheet metal parts for our motorcycles assemblies. Worked on PPAP and APQP processes for parts approval.

Planned and developed automotive parts for new products. Conducted design studies and developed programs to produce Honda parts locally. Introduced and implemented more than sixty designs change in motorcycle products.

Responsible for new project scheduling and on-time completion of orders to the suppliers. Worked on the planning and execution of logistics between the global suppliers and Honda. Managed supplier audits and CAPAs.

Inspected completed works for proper operation and conformance to specification, and safety standards.

Developed Process layout and Routings for punched, pressed, drawn, sheared parts. Prepared cost estimation for products. Involved in facility and equipment modernization. Instituted and controlled quality standards. Performed final Inspection and performed process audits of newly developed parts.

Sep ‘87 -Sep’89 PAKISTAN MACHINE TOOL FACTORY Karachi, Pakistan

Design and Development Engineer.

Developed new products through Reverse Engineering. Major projects included Fuel Dispensing Pump, Deep Hole Drilling Machine and Pantograph Engraving Machine etc.

Education: BS (Mechanical Engineering) Sep.1987

MBA (Operations Management) May1995

Professional Training & Courses

FDA CFR 210 Lead Auditor certification April 2009

Process Validation by AAMI (Association for Advancement of Medical Instruments) Nov 2008

ISO 13485 Lead Auditor certification (RAB & IRCA) Sep 2007

Project Management Professional training July 2006

Focus: Leadership & Strategy Oct 2005

ZOOM: Leading People May 2005

Flawless Consulting Aug 2004

Seven habits of Highly Effective People May 2004

ISO 17025 Lead Auditor certification Feb 2001

Kepner Trego Problem Solving Nov 1999

Customer Supplier Partnership June1999

Team Leader Training April 1999

ISO 9000 Lead Auditor certification (RAB & IRCA) May 1998

Professional Cert.

Certified Quality Engineer (CQE) June 2000

Certified Six Sigma Black Belt Dec. 2001

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