Quality Management
Resume:
Tofazzal Hossain ********@*****.***
San Diego, CA-92126
Areas of expertise
21CFR 820, IVD 2017/746 (98/79), ISO-13485, ISO-14971, CFR-Part 11, Aerospace
Quality management system, CAPA, FDA 483
Internal Audit, ISO 9001, cGMP, Complaints
HIPPA compliance, Supplier Quality, NCMR
Test Method Validation, Gage R&R, DOE, ANOVA, Process Validation/Verification
Software Quality, Design Control, DHF, Risk management, FMEA, SPC, Process Capability Study, AQL Sampling, ANSI/ASQ Z1.4
Six Sigma Black-Belt, Statistics, DMAIC, Process improvements, Lean Manufacturing, Kaizen, Cpk, CE marking, Technical file, IVD
Computer software
MS Office, Stat-graphics, Mini-Tab, Agile
Master Control, SAP, ETQ, EZDOC, ensur
Track-Wise, Visio, SAP, Documentum
ISOtrain, Grand Avenue, JIRA
PROFESSIONAL EXPERIENCE
Quality Consultant, Medical Device Industry, San Diego, CA 04/2016 to Present
QUALITY ENGINEERING/QUALITY SYSTEMS
•Design Quality Engineering support to new product development (NPD) team including Design Controls, Risk Management, quality systems, quality plans, supplier qualification, SPC, design history file and ensure that product quality meets or exceeds regulatory requirements.
•Participate on design transfer and improvement project teams
•Developed risk management plan, DFMEA, PFMEA and user FMEA
•Review and approval of process validation documents including IQ/OQ, PQ, MVP and equipment qualifications.
•Support QC inspections including statistical sampling plans for incoming, in-process and finished goods.
•CAPA owner and managed quality systems including CAPA, NCMR process, SPC, CE marking, customer complaints, Change control, training, labeling, matrices and etc.
•Manage Master Control, document control, change control and working as a Master Control administrator.
•Perform internal audit and supplier audits, develop corrective action plans and owns CAPAs.
•Conducted management review meetings including presentation and preparing the slides, statistical data analysis and trending of various quality data (NCMR, RMA, Complaints, CAPA status, internal audit status, supplier quality and etc.)
PatientSafe Solutions, San Diego, CA 10/2013 to 02/2016
QA ENGINEER
Managed quality systems (Software and hardware) including CAPA, SCAR, internal audits, customer complaints, Management review meetings, process improvements, document control process and change controls.
Review and approve software deliverables including Software Development Plans, Verification Plans, Validation Plans, User Requirements, Functional/ SRS, and Design Documents.
Created Software Risk Management Documents, software FMEA, Traceability Matrices, and etc.
Facilitated weekly RMA meetings including statistical data analysis, SPC, trending, root cause identification and corrective actions to resolve customer complaints
CAPA owner and Managed CAPA process including root cause analysis, risk assessment, corrective actions, effectiveness verifications and closing of CAPA on time and respond to FDA.
Primary contacts with FDA for CFR compliance, FDA audit response, registrations and follow-up communications with the agency
Conducted management review meetings including presentation and preparing the slides, statistical data analysis and trending of various quality data (NCMR, RMA, Complaints, CAPA status, internal audit status, supplier quality and etc.)
Managed HIPPA compliance including employee training and audit.
Johnson and Johnson, Irvine, CA 07/2012 to 09/2013
MANAGER QUALITY ENGINEERING
Managed quality engineering group including problem solving, risk management, process validation, process control, Six-Sigma process improvements and DIR (do it right) program
Provided Quality Engineering support to NPD team including Design Controls, Risk Management, test method development/validation and ensure that product quality and compliance with regulatory requirements.
Led multi-functional Continuous Process Improvement teams including six-sigma process, identifying critical characteristics, implementing control charts, conducting DOE for process optimization, Gage R&R study to determine and reduce measurement system variation and etc.
Managed Return Material Authorization (RMA) process including disposition and corrective action
Conducted management review meetings including preparing slides, data analysis of NCMR, customer complaints, trend analysis on top 5 issues, SPC and corrective action plan.
Conducted Kaizen events on NCMR and batch record processes and made significant improvements by reducing unnecessary steps within the processes
Merck KGaA, San Diego, CA 02/2011 to 06/2012
MANAGER QUALITY ASSURANCE
Managed QC Labs including test scheduling, test priority, turn-around time, creating standardized test methods, NCMR, MRB, root cause analysis and corrective actions.
Managed document control dept including change control, CAPA, complaint, training program and MRB process
Managed internal audit program and acting as quality representative for customer and regulatory/ISO audits
Manage QC Inspection (receiving, in-process, finished goods), lot release and label controls
Implemented quality metrics to monitor QA and QC performances and to drive process improvements and reduce cost of quality
B. Braun Medical, Inc., Irvine, CA 12/2009 to 01/2011
MANAGER QUALITY ASSURANCE
Managed QC and quality engineering group including QC Labs, quality engineers, QC supervisors, technicians, receiving inspections, in-process inspections, rework inspection, finished goods inspection and product release.
Managed departmental budget, hiring employees, mentoring and training new quality engineers in risk management, SPC, six-sigma process, DMAIC methodology, AQL, DOE, GD&T, sampling techniques and etc.
Set-up employee reward program to improve productivity, performance and to create positive work environment.
Reduced cost of quality significantly by eliminating unnecessary steps within manufacturing and quality. Saved over $600,000.00 annually by transferring line-clearance process from quality to manufacturing.
Led multi-functional Continuous Process Improvement teams including six-sigma process, identifying critical characteristics, implementing control charts, conducting DOE for process optimization, Gage R&R study to determine and reduce measurement system variation and etc.
Amylin Pharmaceuticals, San Diego, CA 04/2007 to11/ 2009
QUALITY ENGINEER
Created new quality engineering group to support new product development for the drug delivery device
Managed the coordination and control of supplier quality, new product development, design control function, supply chain, statistical data analysis, and other quality functions as needed.
Actively participated in the design control activities including creating a design and development plan DDP.
Defined all the deliverables for each phase of the design control process, developed risk management plan, developed quality plan, performed Hazard analysis, AFMEA, PFMEA and managed DHF.
Supported and interacted with various auditors including FDA, ISO 13485 and internal audits
Abbott Vascular, Temecula, CA 12/2004 to 04/2007
GROUP LEADER QUALITY ENGINEERING
Managed resources of the entire Quality engineering staff to ensure that internal and external goals are accomplished. Identifies potential compliance issues and takes corrective measures to prevent them.
Facilitated and chaired the weekly CAPA and monthly quality management meetings to review all manufacturing data, customer complaints, supplier issues, facilities issues, SPC, environmental monitoring issues and etc.
Boston Scientific, San Diego, CA 01/2000 to 12/2004
SENIOR QUALITY ENGINEER
Provided quality engineering support for the development of new and significantly changed medical devices, including; design verification, design validation, FMEA's, SPC, risk analysis, DOE, etc.
EDUCATION TRAINING
Master of Science, Statistics, University of Dhaka, Bangladesh
Bachelor of Science, Statistics (emphasis in Math), University of Dhaka, Bangladesh
Lean mfg., Six Sigma -University of California, San Diego
Advanced TQM/SPC – San Diego State University
PROFESSIONAL TRAINING
Process Validation, Design Control, Normality analysis, Supplier Quality management, sampling techniques, Risk management, and FMEA – Abbott Lab/Boston Scientific Corporation / Ely-Lilly and company.
Do it right (DIR) and DMAIC methodology- Johnson and Johnson
ISO 13485:2016 Trained by BSI
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