Quality Engineer Project Management

SUBIR BASU

**** ** ********* **.

San Jose, CA. *5148

408-***-**** (Cell)

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

OBJECTIVE

SKILLS

Accomplished Green Belt Six Sigma Certified Senior Quality Engineer; interest in leading role of a Sr. Quality Engineer/Supplier Quality Engineer/Quality Manager position in a growth-oriented and challenging Company

Vendor Management, supplier co-ordination, Inventory Planning, JobBOSS, SAP ECC Warehouse, Oracle EBS 11i ERP, Oracle Agile PLM, Capacity Planning, CpK, PpK, Design Control,, Risk Analysis, TQM, SAP ERP, SAP PP, SAP MM, Oracle Agile PLM, PLM Arena, Oracle EBS 11i ERP system, MRB, TQM, Lean Engineering, Kaizen methodology, JIRA, Troubleshooting issues, Capacity Analysis, Quality Plan, Quality Internal and Supplier Audit, Equipment Validation, Verification,, Blue Print reading, Six Sigma Green Belt, Statistical Analysis, Electro-Mechanical Device, Protocol, Reports, Calibration, URS, SRS, GAMP V, cGMP, GDP, Solid works, PDM,, Confidence interval, Incoming Material inspection, GR&R, Oracle Mfg., MPI, Medical Device, CMM, Data Collection

EXPERIENCE

Jarvis Manufacturing, San Jose, Sr. Inventory Planner 11/23 - Present

Coordinate Inventory planning for received goods, in process routed parts, parts in inspection and Serviced part using JOBBOSS ERP system and sharepoint.

Managed Procured Part Inventory and receiving inspection data analysis using JOBBOSS ERP system to update part and Material inventory in production and quality. Managed creating and updating production routing, P.O. receiving parts, reviewing purchasing document, retrieved Manufacturing SOP, WI, MSDS, interpretation of Solid view Drawing and Part and quality system related documentation.

Used Oracle Agile PLM to retrieve drawing for parts, submit ECO, create Part No. MPN and BOM. Control Chart, Quality Plan Process Control Plan for Machined Aluminum, Steel, Non-Ferrous, Ceramic and Plastic parts in compliance with ITAR, ISO 13485 and ISO 9001.

TCS Inc. Sr. Quality Engineer

Client: Johnson & Johnson Inc. 02/21 – 11/23

Managed design review to ensure meeting Design control requirements, coordinated with supplier relating rejection and quality assurance documentation and issuance of SCAR, engaged in evaluating safety and performance of electrical medical systems in compliance with EN IEC 60601-1, coordinated with Incoming Quality Inspector relating FAIR, reviewed FAIR Inspection Report, used CMM, ANSI Y 14.5, Tolerance analysis and GD&T per specification. Initiated and supported NCMR coordinating with manufacturing. Worked on Validation, IQ/OQ Protocol, Report for Catheter Assembly and Mechanical Parts.

Engaged in manufacturing and process control of laser welding, soldering connectivity and fusion bonding process and engineering study and statistical analysis for EZ Steer, Thermo-cool, ablated bio-compatible Catheter assembly. Conducted FMEA and ISO 14971 for Risk and Hazardous Analysis. Engaged in interpreting drawing including GD&T, specification, perform tolerance analysis, coordinated with cross-functional team members with part AQL relating decision making for parts acceptance and rejection. Engaged in internal audit, supplier audit and non-conformance.

Worked on Incoming Parts list review Inspection data and documentation and make decision.

Used SAP ERP system to identify the location and quantity of Parts, and Oracle Agile PLM concerning Parts location, status, blocked invoices, Goods receipt, inventory control reliability in SAP ERP and SAP WM system, retrieving and interpretation of drawing.

ITSJ Group, San Jose, CA Director of Operations & Quality 09/20 - 01/21

Managed manufacturing and quality of PCB Quoting, transfer and set up of PCB Assembly equipment. Managed quotes, BOM, Gerber files, Worked on internal audit, NCMR, Created Process flow, visual aid, managed quality of PCB Assembly process in compliance with IPC 610A.

Created BOM, interpreted drawing, Co-ordinated with sub-contract assembly, inspect in-process PCB assembly. Managed procurement of components used for PCB Assembly for Government customers.

Infotree Global Inc. Palo Alto, Sr. Supplier Quality Engineer 02/20 - 08/20

Client: Siemens Healthineers Inc.

Coordinated with Part Supplier relating part compliance, declaration of conformance and analyze the substance and composition of material, CoC and Full material disclosure in BOM assembly and AML Part system, maintained upcoming RoHS substance declaration and monitor the responses making decision relating part declaration compliance for Endoscopic device.

Engaged in SAP RM Med and SAP MM for Ultra Sound Equipment Manufacturing Part BOM structure and AML Compliance analysis in compliance with EU MDR, worked on DFMEA for Risk analysis, verification of part compliance status relating ultrasound device component assembly, REACH, RoHS 21, WEEE part compliance analysis and upcoming ROHS restriction comparing Silicon Expert Part management system, XPedition EDM Library, decision making of selection of parts in compliance with 2017/745 EU MDR, exemption analysis, maintained and updated RM status, new RM set up, in SAP RM Med, approval of ECOs relating new parts and AML updates in Mentor Graphics EDM Library cockpit Applications, coordinated component engineering, manufacturing and R&D teams with decisions relating uploading MRF documents, BOM, AML and material declaration files into system using SAP RM Med.

Cognizant Technology, Consultant 07/ 19 – 02/20

Client: Abbott Laboratories, Alameda, CA Sr. Quality Engineer

Managed manufacturing process capability analysis and validation activities of Blood Monitoring Device products, executed destructive testing failure analysis such as of Blood Strip products, involved in PFMEA, Engineering study report, validation, IQ/OQ Protocol and Reports, SOPs, QMS procedure, executed confirmation engineering studies to come up with decision relating failure of products during validation.

Managed Engineering Change management using Oracle Agile PLM tools for BOM creation using ECO, MCO and AVL.

Infosys Technology, PM Consultant 03/16 - 07/19

Client: Apple, Sunnyvale, CA Inventory Planner 01/ 18 – 07/19

Managed Capacity planning of consumer electronics parts using SAP ERP system, safety factor, Sub-contractor Equipment and tooling inventory, Demand planning Report and Sales Forecast.

Used Jira and Radar for issue resolution, track project schedule, Central Station for Incident Request and Service request, Espresso for Change request. Coordinated with cross-functional team relating capacity planning, used Omni Graffle for Dashboard creation for KPI of P1, P2 aged Incident tickets for LOBs, troubleshoot relating issue resolution using Radar, Jira, Espresso, Central Point.

Client: Jabil Circuits, San Jose, CA Quality Engineer 09/16 – 01/18

Managed quality rejects coordinating with sub-contract assembly relating PCBs, Sub-Assembly, SCAR, test procedures, design, tooling, fixtures, resolving solder rejects relating screen printing, stencil design, reflow profiling, curing, thru hole assembly, aqueous cleaning process, complying with IPC 610A, training operators, writing process and quality documents such as SOP, WI, SMT Component selection in line with ROHS and REACH compliance, Design for Manufacturability, Design and Blue Print review, co-ordinate with supplier relating supplier audit, supported internal and external audit, coordinated with cross-functional team for supplier selection rating approval using metrics, worked in CAPA team relating V&V, deviation, root cause analysis, worked on validation, IQ/OQ, PQ, QMS, selection of parts, document for part assembly.

Lead NPI Project Team in the NPI/PMO process, design review to ensure appropriate design control, apply NPI-PMO process structure using PPQP, Lean Engineering, Kaizen methodology, BOM Validation, packaging and Equipment Design Review, Resource planning, apply NPI-PMO process structure and effective execution in every phase including associated gate reviews, comparison of configuration of Build Assembly in ERP Visual, Cell Fusion and match the Process Flow diagram in QIS, host weekly status meeting of product builds, product issue resolution and co-ordination with vendor regarding PCB issues, electro-plating and painting of sheet metals.

Client: Boston Scientific, San Jose, CA Quality Manager 03/16 - 09/16

Lead cross-functional teams and managed development of Medical Device NPI project, process validation, supplier qualification and equipment validation activities, IQ/OQ, PQ, OVQR, Process Mapping, involved in Design control, managed TQM Meeting, worked on Deliverable Status Log, Work instruction and creating Procedure for Item Numbering, AVL and BOM for Aura Fiber for Aura XP Laser Therapy system and Coaxial Endostat Fiber for Urologic and Pelvic Health system in compliance with GMP requirement for a Medical Device company. Wrote SOP, developed manufacturing processes, process flow and trained production personnel. Used Windchill PLM and Agile PLM system.

PG&E, IT Energy Supplier Management

Project Manager-Vendor Management 10/ 13 – 03/16

Managed coordination with suppliers relating Processor, hardware procurement, inventory, troubleshooting issues on releases manage multiple stakeholders across multiple projects

Managing targeted new budgeted Projects with average $5 Million annually.

Manage multiple Energy Compliance Project with Financial Forecasting, budgeting, monitoring of actuals spent, performed comparative variance analysis with actual expense resource allocation. Managed Project Risk, Project Plan, Forecast and Resource Planning, Staffing Profile, addition users, roles and privileges, Budget Estimate for the project. Strong experience in both Waterfall and Agile Scrum methodology. Managed Project success check, Project Gate Exit review, Project status.

Worked on change management, product life cycle and BOM management.

Project Manager- Consultant, Cognizant Technology 09/12 – 10/13

Client: Alexza Pharmaceuticals

Assessed Supplier Qualification process, supplier audit, SCAR, design Validation master plan, VMP following GAMP V, CAPA, NCMR, URS, SRS, FRS, SDD, IQ/OQ, PQ, DOE and FMEA for validation of various equipment installation and upgrades in the finishing Assembly line consisting Laser Marker, laser Welder, Pick & Place station, UV Inspection Machine, Testing line, In-feed and out feed conveyor for Plastic Molded Assembled Inhaler Medical Device assembly products, vendor audit, performed process validation that includes PV Protocol and Reports, conducted DOE. supported internal and external audit, Co-ordinated with Engineering Manager, established validation plan and criteria.

Involved in supplier part qualification process that includes, design review, PFMEA, process and tooling validation, process capability analysis, and FAI using AS9102. Participated in preparing the Quality Plan for manufacturing Plastic injection molded Assembled parts, assessed AQL level of supplier parts and COC, design review of molded parts and components, participated in FMEA.

Sr. Supply Chain Engineer- Consultant, Infosys Technology 03/11 – 09/12

Client: CISCO Systems, Project Manager Consultant

Coordinated with Russia sub-contract assembly relating manufacturing and supply chain of Smart Grid, Blades, Router products. Performed Supplier Audit. Coordinated with cross-functional team relating supplier selection and performance using performance criteria and rating of suppliers. Coordinated with Subject matter expert regarding implementation of Fulfillment to Delivery on Russia Country enablement project of limited product line. Familiar with Procure to Pay. Prepared BRD, Process map on each components of the project.

Engaged in managing test Trial on Planning and Forecasting process, Forward Logistics, reverse Logistics, Manufacturing co-ordination with sub-contractors, Fulfilment and ECM AS Is and TO Be process mapping and Test cases development and execution.

Project Manager, Abbott Diabetes Care. (Abbott Lab Inc.), Alameda, CA 05/10 – 03/11

Developed Quality Plan, NCMR for new processes and updated MPI for Blood Glucose Device, software quality engineering and TQM using 8D+ problem solving and DMAIC methodology, coordinated NCMR, FMEA for existing processes for Freestyle Test Strips used for Blood Glucose Monitors in compliance with ISO 13485 Standard, GMP and GDP.

Achieve significant cost savings implementing change control process in ADC Diabetic Strip Assembly process, Managed and generating Change Request, VSR, IQ/OQ, PQ for Systems and Equipment using Agile PLM. Worked on Process Extension project in Manufacturing change control process. Participated in Companywide Quality audit, Prepared Project Plan, Schedule, work Break down structure. Developed and executed Production Test Plan and protocol. Used Agile PLM to add, review and approve MPI, ECO, BOM, ECR. Responsible for ensuring that all documentation accurately reflects the current status of changes and outstanding issues so that process, product quality is in compliance with ISO 13485 requirements standard by coordinating with SWQA team.

Sr. Quality Engineer, Biosense Webster Inc. (J&J Company), Irwindale, CA 07/09 – 05/10

Engaged in Part qualification process that includes Design Review, Dimensional tolerance analysis, process validation, DFM, DOE and FAIR for Bonding Material, Tooling for Ez-steer, thermo-cool, ablated catheter assembly. analyzing Process, Measurement data for IQ/OQ and PQ Protocol and report.

Evaluated safety and performance of electrical medical systems in compliance with EN IEC 60601-1.

Worked on Failure analysis of Pull tested parts, process capability analysis of Tensile strength of spot-welded parts, chemical etching and cross-sectional analysis of welded parts. Developed production quality inspection plans for assigned items focusing on defect prevention through the application of knowledge of QA methods, product specifications, and principles. Interacted with supplier relating design review, selection, screening and evaluation, first article inspection, of BSS, Dome shell, tube, Puller Wire, designing Tooling and Fixture for Laser, Ultrasonic Welding machine. Prepared Quality Plan for Palladium Metal, procedure for Pressure and Flow Test of Catheter. Coordinated with Supplier for material selection, SCAR, supplier audit, bonding material, micro-component and guide wire selection, Material and Components Inspection & Corrective action and GD&T Tolerance analysis.

Reduced Cost involving in design control process, statistical analysis, PFMEA, Process control, co-ordination with supplier regarding material and supplier selection, design, implement and validation of ultrasonic welding protocol and reports of Catheter Assembly process, co-ordinated with QE relating establishing statistical process control of Nd YAG Laser Spot and Seam Welding of Platinum Palladium Alloy dome shell-Biosensor Support in joining and bonding process for new products such as Thermo-cool Irrigated Tip Ablation Catheter, EZ Steer Thermo-cool Catheter Assembly, Train Technicians for new process. Conducted validation protocol and reports that includes Destructive Test e.g. Pull test, Buckle Test, Accelerated Aging, Thermal Cycling, Tensile and deflection Test Provide Project Status update.

Achieved cost savings for Company implementing Quality Plan, approving ECO, SOP, WI, leading FMEA team, generating validation documents using PDM, GxP, ISO 13485, TL9001, developing Design of Experiments using Minitab, performed linear regression analysis,

Sr. Supplier Quality Engineer, Iron Key Inc., Mountain View, CA 2008-2009

Supplier Quality – Coordinated with Supplier and Sub-contractor relating PCB assembly, epoxy curing, case mechanical assembly drawing interpretation & approval, reviewed spec., made decision based on engineering analysis of new epoxy material and NCMR disposition, created process flow for USB Drive assembly process. Audited, assessed and maintained relationship with supplier, issued SCAR.

Quality Inspection - Implemented First Article, In-process Inspection criteria and alignment of inspection process and documentation with suppliers, in-house, reducing reject trend for continuous process improvement using SPC, ANOVA, GR&R, DMAIC methodology

Quality Documentation – Developed documentation methods and test procedure, control plan, process flow, BOM, ECO, EV, PM and Work orders. Maintained existing documentation

Failure Analysis – Conducted methodical F.A. on Encrypted Memory Drive, analyzed data, prepared Reports on findings and implemented corrective action

Internal and ISO Audit: Represented Quality Group for ISO 9000, IPC 610 A and internal audit, issued non conformance report and follow thru corrective action for process improvement

Supply Chain Planner, SanDisk Corporation, Milpitas, CA 2005 – 2008

Coordinated with supplier, sub-contractor and relative departments relating capacity planning of MSPD, USD, SD Card product, supplier, subcontractor and relative departments driving issues on capacity planning, Yield and productivity, Safety factor, Demand report and Sales Forecast. Prepared Capacity Planning Report upcoming 4 weeks.

Implemented Six sigma tools, used Camstar MES system, prepared ECO, MPI, Spec., reviewed and approved set up Chip shooter, pick & place as a part of Supplier weekly process performance audit, reviewed Reflow profile, Screen printing and SMT assembly process issues, programming and debugging production, cross-sectional analysis of BGA solder joints, BGA void analysis using x-ray, SAM, BGA rework process, solder paste height measurement, qualify, test electronic and electro-mechanical components, process control, NPI & trouble shooting. Interacted with Design Engineers relating PCB Design Guidelines and Gerber files.

Prepared spec. proposal, generate, manage and maintain ECO, BOM, spec., Performed Equipment Utilization, Cycle Time and UPH Analysis, participated in Capacity Planning, Yield analysis process based on forecast, Up and down time

Sanmina Corporation, Fremont, CA. - SMT Quality Engineer 2001 - 2005

Created MPI, BOM, AVL. Qualified cross-referenced and alternative components. Achieved 80K per annum by reducing yield loss effecting from solder mask defects e.g improved process flow for SMT and Thu-hole PCB assembly process such as Solder ball, solder bridging, Tomb stoning, insufficient solder, screen printing and Reflow process profiling, conforming to IPC-610A, Lead free ROHS component.

Addressed, detected and resolved solder rejects coming from Fuji CP and IP Machines, DEK Screen printer, Heller Reflow oven profile set up, optimizer analysis in Reflow oven, based on IPC-610-A standard, member of MRB Team to analyze root cause, drive quality issues until resolution. Retrieved Gerber data containing Aperture files, X-Y data, AOI and Troubleshoot SMT solder rejects.

Justified selection of new equipment and saved Inventory and cost for company by 80% to $85K. Generated DFM reports. Resolved process and component related problems. Supported design group, interfaced between purchasing, Quoting, Quality & Test group.

Involved in DFM, PCB material, board design using IPC-D-782A, solder masking, process control of Wave soldering and SMT line coordination of Burn-in Board machine. Involved in root cause analysis of SMT insufficient solder, bridging, material and process consideration in over thickness issues, plating, coating, pre-preg, solder mask selection and handling issues.

Analyzed defect data, measured and controlled manufacturing line performance by using six sigma concept. Drove prototype embedded multilevel computer assembly NPI project from concept to volume manufacturing. Interfaced with Design Engineering, manufacturing group to ensure product Design changes effective and to introduce new product to manufacturing.

EDUCATION

B.S. Metallurgical Engineering, National Institute of Technology, Durgapur, India

PG Diploma, Business Management, Jadavpur University, Kolkata, India

M.S. Microelectronics, San Jose State University, completed 18 Graduate units.

Certificate, Six Sigma Green Belt, Data zinc Inc.

Certificate, Design for Manufacturability, U.C. Berkeley Extension.

Certificate, Solid works, Evergreen Valley College, San Jose, CA

Completed a Comprehensive Certificate course in Semiconductor Process and packaging Technology, SEMI, affiliated with San Jose, State University

Published a United States Patent on optimization on Transporting and Packaging of 3D Dentition Model that reduced Cycle Time, Risk and improved Safety criteria

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