Quality Engineer

TOFAZZAL HOSSAIN

***** ******** *** 858-***-**** HOME, 858-***-**** CELL

San Diego, CA 92126 e-mail: ***********@*****.***

QUALITY MANAGEMENT/ENGINEERING

Medical Device, Design Control, FDA QSR, Process Validation

DHF

TQM, DOE, JIT, Supplier Quality ISO 9001: 2000, Boeing

D1-9000

Lean Manufacturing, Lead Reliability, MTBF, SPC

Auditor

Black-belt/Six Sigma Quality Risk Assessment/Management,

FMEA

MIL Stds., Process Capability Aerospace/Defense

PROFESSIONAL EXPERIENCE

B. Braun Medical Inc. Irvine, CA

2009 to Present

Manager, QC and Quality Engineering

. Managing an organization of 56 employees including quality engineers,

QC supervisors, technicians, and inspectors.

. Managing departmental budget, hiring employees, mentoring and training

new quality engineers in risk management, SPC, six-sigma process, AQL,

DOE, sampling techniques and etc.

. Set-up employee reward program to improve productivity, performance

and to create positive work environment.

. Responsible to release finished goods by reviewing and approving batch

records, non-conformance reports and other related documents

. Reviewed and approved CAPA, deviations, validation reports and change

controls

. Developed process improvements program to reduce cost of quality and

to implement process control techniques.

. Initiated cost of quality reduction program including elimination of

un-necessary QC inspections/test, implementing proper AQL levels based

on criticality of defects and its associated risks.

Amylin Pharmaceuticals, San Diego, CA

2007 to 2009

Associate Director, Quality

. Managed and created quality engineering group including hiring,

budgeting, delegation of assignments, mentoring junior quality

engineers and etc.

. 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. Managed and maintained DHF

file.

. Root cause analysis of customer complaints and production issues

including corrective actions.

. Performed DOE and ANOVA analysis to resolve manufacturing issues and

process optimization including implementation of SPC, Gage R&R study

to determine and reduce measurement system variation and etc.

. Worked cross-functionally with production, mfg. Engineering and R&D to

resolve product quality issues

. Conducting process validations/verification (IQ/OQ/PQ), including

preparing and reviewing protocols, reports, Master validation

plan/report, validation sample size determination, statistical

confidence limits, conducting process normality analysis, process

optimization, Ppk, Cpk and etc.

. Worked as a subject matter expert (SME) for design control, Risk

management, process validation and statistical methods of data

analysis

. Interfaced with different contract manufacturing sites and suppliers

to resolve quality issues and process improvements

Abbott Vascular, Temecula, CA

2004 to 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, environmental monitoring issues

and etc.

. Monitored quality processes to ensure compliance with FDA and

applicable international regulations when appropriate.

. Implemented process control techniques, including developing process

flow charts and identifying key characteristics and implemented SPC

charts to monitor, control and improve mfg. processes.

. Developed effective and meaningful data collection system including

manufacturing processes, SPC, field failure, receiving inspection and

etc.

. Performed Risk analysis and developed process FMEAs to identify

potential hazards and mitigation plan

. Visit and audit suppliers to resolve quality issues.

Boston Scientific, San Diego, CA

2002 to 2004

Sr. Quality Engineer

. Prepared, reviewed and approved process validation protocols and

reports.

. Provided quality engineering support for the development of new and

significantly changed medical devices, including; design verification,

design validation, FMEA's, Risk analysis, DOE, etc.

. Provided quality support to production floor, isolation,

identification, and rectification of production problems, verification

of engineering changes, MRB decisions, CAPA and etc.

. 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.

. Reduced cost of quality by eliminating unnecessary QC inspections,

using statistical methods and by identifying critical characteristics

and implementing process verification and process control techniques.

. Managing Supplier quality program including setting-up database to

monitor and control supplier quality, Trend analysis, involved with

supplier corrective action activities, Supplier audits, helping

supplier to improve quality by implementing SPC and etc.

. Coached and mentored manufacturing and quality engineers in process

validation, statistical methods, DOE, SPC etc to improve manufacturing

processes.

. Implemented process control techniques including developing process

flow charts and identifying key characteristics and implement SPC

charts to monitor and control mfg. processes.

JOMED, Inc., San Diego, CA 2000

to2002

Manager Quality Assurance

. Responsible to monitor production scrap and non-conformities, manage

CAPA program, weekly report on quality issues to management and

implement corrective and preventative action.

. Managed quality engineers/technicians (7 employees), and prepared

departmental budget and manpower requirements.

. Worked with manufacturing to resolve quality issues using statistical

methods, including DOE, analysis of variance, gage R&R study, SPC,

fish-bone diagram and etc.

. Review customer complaints, perform trend analysis and evaluate

returned devices to provide quality input for root cause and

corrective action.

. Conducting process validations/verification (IQ/OQ/PQ), including

preparing and reviewing protocols, reports, Master validation

plan/report, validation sample size determination, statistical

confidence limits, conducting process normality analysis, process

optimization, Ppk, Cpk and etc.

. Developed audit program, including audit schedule, training, managing

and conducting the audits as a lead auditor.

. Work cross-functionally with production, mfg. Engineering and R&D to

resolve product quality issues.

GOODRICH AEROSPACE, Chula Vista, CA 1987 - 2000

Senior Quality/SPC Engineer

. Implemented SPC techniques in different manufacturing processes

including machine shop, fabrication, subassembly welding, and assembly

area.

. Provided quality support to production floor, rectified production

problems, interfaced with customers and vendors to resolve quality

issues.

. Led multi-functional Continuous Process Improvement and Kaizen teams.

. Improved several manufacturing processes by implementing Lean/Kaizen

program.

. Reduced inspection time by 25-35% in several areas.

. Reduced non-conformance material from the supplier significantly by

instituting SPC at the supplier house.

GOULD INC., MEDICAL DIVISION, Oxnard, CA 1985 - 1987

Senior QA Engineer

THE VENDO COMPANY, Fresno, CA 1984 - 1985

Senior QA Engineer

TERMINAL DATA CORP., Simi Valley, CA 1982 -1984

Reliability Engineer

EDUCATION

Master of

Science, Statistics

Bachelor of Science, Statistics (emphasis in Math)

PROFESSIONAL TRAINING

. Lean mfg., Six Sigma -University of California, San Diego. Advanced

TQM/SPC - San Diego State University

Process Validation, Design Control, Normality analysis, Supplier

Quality management, sampling techniques, Risk management, and FMEA -

Boston Scientific Corporation,

Computer - MS word, stat-graphics, Mini-Tab, Power point

ASQ member

Contact this candidate