Electrical and Quality Assurance Specialist

BISHWANATH BEN CHOUDHURI

*** *. ******* ****, ****, CA 92821

Mobile: 714-***-**** E-mail: **********@*****.***

US CITIZEN

•Over 40 years of experience in ISO Program Consulting in Manufacturing, Quality Assurance, Supply Chain Management, Product Failure Analysis and hands on application experience in Design Control, implementing PFMEA, 5WHY, DMAIC, Six Sigma, Mistake Proofing, SPC and product FAI review, ISO internal and External Auditing and proto-type approval for production run.

•More than 8 years manufacturing experience in Food manufacturing industry. Responsible for managing ISO 22000:2018 Food Safety Management System (FSMS), Hazard Control Plan, HACCP Analysis, PRP, cGMP, implementation and providing companywide employee training, performing extensive Internal and on-site supplier audits Audits and developed document control system and established Food Safety Records retention and document control system.

•Possess more than 10 years of experience in developing, implementing Quality Management System Regulation ( ISO 9000, ISO 22000, QSR and ISO13485, AS 9100), Risk Management Analysis, product verification, validation, approval and product release process (PRP)

•Worked on a Class-III medical device (Saline tube) manufacturing company for developing and implementing procedures for ISO13485 QMS program in compliance with FDA 21CFR 820 Quality System Regulation (QSR) requirements

•Possess more than 8 years of experience in performing Supplier Audits, Supplier Source Inspection (SSI) including application of quality tools in identifying and resolving CAPA and Supplier Corrective Actions (SCAR) related to Class-III medical devices

•Possess more 15 years of experience in providing consulting services to Manufacturing, Nuclear, Aerospace, Department of Defense (DOD), Automotive and Medical device manufacturing industries to achieve, ISO 22000, ISO 9001/AS 9100/ ISO/TS 16949/ ISO 13485 Certification

•Major strengths in the areas of Procedure Development, Design Control, Design review Design change, Design Validation &Verification, Corrective & Preventive Action (CAPA) Management, SPC Training & Implementation, Internal and Supplier Quality Audits

Education:

Bachelor of Science in Electrical Engineering Technology June 1987 Northeastern University, Boston, MA

Training/Certifications:

Certified ISO 9001 Internal Auditor & Completed RAB Accredited ISO 22000, ISO 9001, ISO 14000 Lead Auditor Training & Certification provided by Independent ISO 9000 accreditation Registrars

Supervisory Phase I and Phase II development training and certification

Completed ASQ Certified Six Sigma Black Belt (CSBB) Course

Completed Training, Certification in ITAR, Ethics & Compliance at Aerojet Rocketdyne

Certified MRB member for CAPA Management at Aerojet Rocketdyne by Lockheed Martin Missile & Fire Control System

Hazard Analysis and critical Control Point (HACCP) and cGMP

Senior Member - American Society of Quality (ASQ)

Professional Experience:

Principal Consultant and Lead Auditor

ABC Quality Consulting Services, Brea, CA Oct’ 2007 – Sep’ 2016

Sep’ 1991- Feb’ 1995 Sep’ 2005 –Feb’ 2007

ISO Program Coordinator & Management Representative 10/2016- Present

Kopykake Enterprises, Torrance, CA 90505

•Working as a consultant and Food Safety Team Leader (FSTL)/MR for implementing and maintenance of ISO 22000:2018 Food Safety Management System (FSMS) program in a food manufacturing environment since October 2016.

•Performed process mapping, developed process control plan and performed analysis of project management requirements. Performed verification, validation protocol (IQ/OQ/PQ), Root Cause Analysis (RCA) of nonconforming products (In-house and customer complaints).

•Assisted manufacturing and Food Safety Team (FST) Members, provided training in cGMP, Food Defense, regulatory requirements, CAPA, Hazard Analysis and Risk based preventive controls determination for Foods, Food allergen preventive controls, sanitation preventive controls, supply chain preventive controls, pest control and sanitation programs.

•Ensured compliance to process changes requirements for CAPA resolutions and close-out.

•Developed and implemented verification and validation Procedures (SOPs), Record keeping procedures, Product Recall plan and developed and implemented corrective and preventive action plan

•Reviewed and approved Engineering and Manufacturing Change orders

•Hands on experience in handling Receiving Inspection (dock to stock),

Aerojet Rocketdyne, Sacramento& Los Angeles, CA Sep’1991-Apr’1992

Senior Quality Engineer Dec’2009 – Mar’2013

•Developed, review, update and implemented Manufacturing Procedure, Shop Travelers to implement ISO9001:2008 and AS9100 program

•Developed and implemented Calibration methods for various gages and measuring devices, Calibration monitoring system, Gage R&R system based on ISO17025 Calibration Procedures

• Maintained Corrective Actions & Preventive Actions (CAPA), Supplier Corrective Actions, Nonconforming Material Control (NCMR) system and provided disposition in conjunction with Engineering MRB Members Chaired MRB meetings for Nonconforming products

•Performed investigation, implementation and monitoring of assigned CAPA and NC projects

•Prepare Inspection Planning sheet (IPS), First Article Inspection (FAI) & Final Inspection Checklist and closely interface production personnel as required

•Used Quality Tools such as PFMEA, C/E, 5WHY & 8D and DMAIC model to address quality issues and for continuous improvements. Performed On-site Supplier Audits & Source Inspection and prepared report and presented to Management Review meetings.

•Achieved Supplier Certification Status with 99.2% Quality Rating Score and obtained Source Inspection Waiver from customer LMFC.

Kaiser Aluminum, Los Angeles, CA Mar’2007-Nov’2009

Senior Quality Engineer & ISO Program Lead Auditor

•Performed and managed day-to-day Quality Assurance Program

•Responsible for driving continuous improvement on Root Cause investigations and CAPA as a core Quality Business process/function(s)

•Responsible for managing ISO 9001 QMS program, Document Control System, Participated in Customer Source Inspection, Management Review, Internal Audits, Supplier Audits, Audit Report preparation and reporting to management

•Corrective and Preventive program management, Internal Audit Training and Certification and performed as Lead Auditor for ISO 9001 and ISO 14001, environmental Management System

•Developed and implemented Calibration methods for various gages and measuring tools, Calibration monitoring system, Gage R&R system based on ISO17025 Calibration Procedures.

Developed Internal procedure for calibration lab including calibration re-call system. Used

Gage R&R methods to identify tools/gages output vs. calibration operator measurements.

Research Engineers International, Yorba Linda, CA Feb’1998-Aug’2005

Quality Assurance Manager

•Responsible for preparation, development and complete document production, training and implementation from ground zero to obtain ISO 9001 Certification

•Extensively involved in Design control, Design review, Design Validation & Verification process including Design Change and approval and release process

•Lead the company to obtain ISO 9001 Certification in the year 2000

•Performed Nuclear/Government/ customer contract review, supplier audits

•Performed Software design review, software design verification and validation, reviewed and approved software test plan and test scripts for various structural software (STAAD-III &ADL PIPE etc.) products for nuclear industries.

•Developed Quality and manufacturing procedures and lead internal Quality System Audits

•Chaired Management Review Board (MRB), product design review (PDR), verification and validation approval process.

•Conducted Training and Certification for employees and management personnel in ISO 9001:2000 Internal Audit course

•Implemented US Nuclear Regulatory Commission (NRC)10 CFR PART 50&10 CFR PART 21 compliance for Structural Software products for Nuclear Utility companies

Hycal Engineering, El Monte, CA Mar’1995-Jan’1998

Quality Assurance Manager

•Performed the role of management representative and lead the company to obtain ISO 9001 Certification in 1994

•Supervised manufacturing and Quality Engineering Activities. Reviewed and established Quality and manufacturing procedures

•Provided training and certification in QMS internal auditors for various employee and management groups

•Performed investigation, implementation and monitoring of assigned CAPA and NC projects

•Performed extensive on-site supplier audits to qualify suppliers for company's Just-in-Time program and requirement of customers

Unitrode Corporation, Watertown, MA Aug’1986 – Aug’1991 (Currently - Micro Semi Inc.)

Quality Control Engineer

•Supervised a large group of inspectors, operators and test technicians for Receiving, in-process and final test of hybrid micro-electronic products, wafer fabrication and switching power supply productions.

Power General Corporation, Canton, MA Jul’1984 – Aug’1986

(a subsidiary of Unitrode Corporation)

Manufacturing Supervisor

•Set-up and supervised assembly station for Uninterruptible power supplies, DC/DC Converters and automated assembly of PCB production line, cable harnessing, testing verification and validation. Responsible for maintaining quality and manufacturing test.

Contact this candidate