Six Sigma Supplier Quality

Baqar Hasan

*** ******** *****, **********, **-**566

************@*****.***

Phone: 510-***-**** (home cell), 510-***-**** (work cell)

Over 30 years of experience in managing factories, plants, and departments efficiently delivering defect free products through Lean and Six Sigma implementations.

WORK EXPERIENCE

Head of Quality reports to VP Ops

Quanergy, Sunnyvale, CA (a LIDAR manufacturer)

May 22 to date

Responsible for product and process quality of LIDAR products including supplier quality, reliability, and compliance to Automotive and ISO 9001:2015 standards.

Implement Lean and Six Sigma in the company for continuous improvements.

Achieve at least 5 sigma level quality

Manage quality at contract manufacturers worldwide

Establish quality KPIs, dashboards

Lead NPI projects on APQP deliverables at every gate

Perform statistical analysis (correlation, GR&R, ANOVA etc.) on Minitab

Train Executive staff on Lean and Six Sigma and lead Kaizen Events

Lead Management Reviews and internal and external audits

Director of Quality reports to CEO

C&H Enterprises Fremont ( a contract manufacturer for semiconductor and aerospace)

Feb. 2017-May2022

Responsible for product and process quality (machining, welding, assembly and fabrication) in compliance to AS 9100 and ISO 9001 standards. C&H is also compliant to ITAR and NADCAP.

Management Representative of the company responsible for conducting quarterly management reviews and internal and external audits

Responsible for the raw material (aluminum, SS, and alloys) and finished goods quality

Responsible for certification of C&H Enterprises to AS 9100, ISO 9001, and ITAR

Responsible for quality engineering, corrective and preventive actions, and auditing

Responsible for Lean and Six Sigma implementation –

oValue Stream Mapping, 5S, Kaizen Events and Error Proofing

Develop Master PFMEA for the company-update through capture of latest failure modes

Implement SPC and out of control action plans for heat treatment, welding and machining processes

Responsible for calibration system complying with NIST Standards

oAssure that all the measurement tooling is properly calibrated, perform Gage R&R (if needed)

Perform statistical analysis (ANOVA, t and F testing, Capability Analysis)

o Design of Experiments to optimize process parameters (if needed)

Responsible for process, facility, utility and test method validations (for medical device

Manage supplier quality processes through planned audits and score cards

omanage sub-tier suppliers

Manage risk management process for the company

omitigate risks to acceptable levels

Train and develop employees in problem solving, TQM tools, internal auditing, lean and six sigma

Director of Quality reports to General Manager

NEO Technology Solutions (a PCB contract manufacturer)

Jan. 2016 to Feb. 2017

Responsible for product and process quality of all products delivered to medical device and other customers.

Management Representative of the company complying with ISO-9001 and ISO-13485 and 21 CFR 820 standards.

Responsible for management reviews, corrective and preventive actions, supplier quality, documentation control, quality engineering, FMEA's, process validation, internal and external audits and continuous improvements in the company

Assure quality of medical devices and Printed Circuit Board Assemblies

Responsible for internal and external audits

Responsible for training employees in Problem Solving, Process Validation, Process Mapping and Value Streaming

Responsible for Continuous Improvements, Lean and Six Sigma

Sr. Quality Manager reports to Director of Quality Systems

Fresenius Medical Care North America Concord, CA

Nov. 2013 to Dec. 2015

Responsible for compliance to ISO 13485, 21CFR 820 standards

Responsible for FDA audits and Adverse Event Reporting, remediation projects

Responsible for managing product and process quality of Peritoneal Dialysis machines

Manage Post Market Surveillance Program for the Concord site keeping Level II type of customer complaints, backlog very low and resolve complaints through failure analysis

Manage Failure Analysis Lab-timely investigate / resolve FDA AIs (additional information requests)

Manage Calibration department and preventive maintenance of equipment

Site Lead for Process Validations, Test Methods Validations, Software Validations, Facilities Validation and Product and Process Validations (PPQ)

Working with cross-functional teams on design transfers and New Product Introductions including 510-K approvals

Work closely on all design transfer phases for the peritoneal dialysis machines

Review and approve all quality documentation related to design changes, process changes and "form, fit and function" issue of components

Authorize ship holds, product recalls, and stop production for non-conformances

Perform Kaizen litzes to improve processes in Failure Analysis and Customer Complaints processes

Train and develop employees in Lean and Six Sigma

Review and approve validation protocols

Perform statistical analysis (Gauge R&R, Anova, Capability Analysis) on Minitab

Assign cost saving Value-add Green and Yellow Belt projects

Comply with cGMP, GDP, ISO-13485 and 21 CFR820 and EU and Canadian Standards.

Responsible for managing UL certification projects for PD and Hemo dialysis machines

Director of Quality, Performance Excellence, & Regulatory Affairs reports to General Manager

Vander Bend Manufacturing, Sunnyvale, CA

Feb. 2012 to Nov. 2013

Management Representative for the company managing the QMS System compliant with ISO-9001 and

ISO-13485 standards

Responsible for company Site Quality processes with a special focus on building to customer design with highly capable processes duly validated (IQ, OQ, PQ) to consistently meet or exceed customer requirements.

Manage and drive quality through effective partnering with the stakeholders to drive process changes and resolve issues for incoming customer product designs.

Manage and drive quality through project management working with marketing, planning, manufacturing, machine shop, sheet metal, assembly to make it "first time right" for the customers

Develop and implement Quality Management System (ISO-9001 and ISO-13485) that meets or exceeds customer requirements (semiconductors, medical devices, others)

Customers served: Intuitive Surgical, Abbott, Varian, Covidien, Google and others

Drive improvement activities to meet/exceed the quality goals using 8D, Lean 6-sigma, process mapping, and review of corrective action plans in Visual Quality

Meet customer quality satisfaction indices on time delivery, six sigma quality level, Return Material Authorizations, Corrective Action Reporting

Meet with key customers weekly on key quality issues and corrective and preventive actions

Lead or manage various process change review boards for changes to design and NPI flows/business processes

Support product and process validation for the customers including qualifying "dock to stock" parts

Lead and project manage key transformation activities and assist in organizational alignment

Set goals, track and drive key performance indicators for entire QA group (sheet metal, machine shop, assembly). Lead monthly CAP(corrective action process meetings)

Plan and execute career development goals for quality managers and inspectors

Sr. Manager Training & CI reports to Director of Manufacturing

Boston Scientific Corporation, San Jose, CA

Jun. 2009 to Feb. 2012

Assure product and process quality for electrophysiology products

Manage training of product builders and engineers

Train employees to meet cGMP, quality and compliance requirements

Train on Problem Solving, TQM tools, SOPs, Lean and Six Sigma( Process Mapping, SPC

Manage shop floor paper work and controlled environment (clean rooms)

Implement Poka-yoke, MES, source Inspections to find permanent fixes

Versatility matrix- implement "One Up One Down" procedures (Flexing)

Work on corporate and site specific corrective and preventive actions

Work with cross functional teams on 5S, Site Metrics (9 Panel), PFMEA, risk management, and safety

Conduct Kaizen Blitzes to improve manufacturing processes

Worked in project team to transfer products to and from San Jose site

Lead projects on TQM, Poka-yoke, six sigma, GOI (graphical operator instructions), MES (training, BOMs) and defect awareness

South Bay Area Operations Manager reporting to Director of Manufacturing

JDS Uniphase - San Jose, CA

Apr. 2004 to Jun. 2009

Responsible for product and process quality for wafer fab and assembly processes reporting to director of manufacturing

oTrain and certify front end (wafer fab) and back end assembly operators for multiple sites

oReduce defects, calculate and monitor DPPMO (defects parts per million opportunity)

oPerform GR&R to qualify operators and do hypothesis testing and t-test

oReduction of scrap in the wafer fab and assembly areas

oPerform weekly Pedigree quality reviews for pumps

Implement Lean and Six Sigma in the Company

Completed Three Waves of Six Sigma Black Belt training for engineers and implemented Yellow Belt training for operators in wafer fab and assembly areas

Managed multiple Green Belt projects realizing substantial cost savings for the company

Responsible for product transfers to Shenzhen and Malaysia

Train the site engineers, validate the processes (Cpk >1.33) and make product abroad

Implemented Kaizen Blitzes in wafer fab and other assembly areas

Calculate RTY (rolled throughput yield) and prevent wafer breakages

Worked as SQE for a period of 6 months. Managed customer issues for laser products (21 CFR 820 compliant)

Total Quality Manager reports to Director of Worldwide Training

Lam Research Corporation, Fremont, CA

Dec. 1994 to Mar. 2004

Manage TQM training for global operation

Develop and deliver LAMP (Leadership and Management Program ) with Organizational Development SMEs

Implement Change Management Training(Force Field Analysis)

Implement Demand Flow Technology

Implement Lean Manufacturing in the company

Implement Program Management, Project Management and Customer Satisfaction training

Train engineers and managers on New Product Introduction Workshop (2d)

Manage DOE and Statistical training

Manage Field Service Training (soft skills)

Conduct Kaizen Events -conducted a 2 day Kaizen event for Finance Group led by CFO.

Manage SITN Program for the Company ( Stanford University)

Developed and managed a portfolio of Total Quality Management and Technical courses.

Re-engineered production lines with IEs to TAKT times

Delivered workshops on Problem Solving and pFMEA, SPC in Singapore, Japan and Malaysia

Trained all the employees in Demand Flow Technology, Lean and Kanban.

Supported engineering and manufacturing training.

Provided Project Management, New Product Introduction, and Customer Satisfaction Training.

Train and Certify on CPIM, CQE, and SSBB certifications. Proctor for ASQ exams (in-house).

Obtained California State Educational Grant of $1.5 million for Lam Research Corporation.

EDUCATION

Master of Science in Industrial Engineering

University of Cincinnati, Cincinnati, Ohio, USA

Bachelor of Science in Mechanical Engineering

NED University of Engineering and Technology, Karachi, Pakistan

Graduate Level Coursework

oDesign for Manufacturability-Stanford University, CA

oTQM (total quality management)-UC Berkeley

oMarketing Management-Keller School of Management

Training and Certifications

oSix Sigma Black Belt- JDS Uniphase Corp.

oSix Sigma Green Belt – American Society of Quality

oProblem Solving- Texas Instruments

oChange Management- Dr. Randal Somers

oSituational Leadership-Center for Leadership Studies

oDesign of Experiments- Dr. Richard Post

oStatistical Process Control- Dr. Richard Post

oLean Manufacturing-Lam Research Corp.

oDemand Flow Technology-JCIT

oProcess and Test Methods Validations- Fresenius Medical Care

oInternal Auditor Certification– Lam Research Corp.

oFacilitation Skills Certification- ODI Boston, MA

oTraining and Development Skills –ASTD

oValue Stream Mapping – JDS Uniphase

oMinitab training

oProject Management- Business Management Systems

oISO-9001:2015, ISO 13485, AS 9100 Rev. D, 21 CFR 820

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