Quality Engineer

Gopal P. Mohanty

***** ***** ****, ********* *****, CA 91381

Tel. 760-***-****, 661-***-****, **************@*****.***

Professional Summary

Over 20 years of experience in the areas of product design and

manufacturing process improvement that include quality system

regulations and standards, quality system audits/regulatory

investigations, complaint evaluation, CAPA/NC, risk management, product

development process/design control, process validation, manufacturing

process control, operations quality such as receiving inspection,

stop/resume shipment; Chemistry/Micro lab management, six sigma

(DMAIC/Lean, DFSS), supplier quality management, regulatory

submissions, statistics, reliability engineering, training, coaching

and consulting. Proven leadership in regulatory compliance,

organizational design/development, project management and obtaining

measurable goals to improve quality processes, and business results.

Education

Executive Education Received from Kellogg and Chicago Graduate School

of Business

Ph.D. in Industrial Engineering (Specialization in Quality), Wayne

State University, Detroit, May 2001

M.S. in Manufacturing Engineering, Wayne State University, May 1992

B.S. Mechanical Engineering, Regional Engineering College,

Kurukshetra, India, May 1987

Certifications

ASQ Certified Quality Manager

ASQ Certified Quality Auditor

ASQ Certified Quality Engineer

ASQ Certified Six Sigma Black Belt

ASQ Certified Reliability Engineer

Professional Experience

Advanced Sterilization Products, Johnson & Johnson, Irvine, CA

Worldwide Director, Quality Operation and Compliance

Feb 2013 - Current

Manage Quality Assurance systems required to support Operations at ASP

facilities globally. Oversee the management of the day-day Quality

Operations activities, which includes: Quality System Remediation and

Harmonization, Design Transfer, Quality Control Acceptance Inspection,

Production & Process Control, Quality Engineering, Ensuring Process

Validation and Verification Compliance, Plant Quality Systems and

Compliance as applicable to Supply Chain, Plant Quality Laboratories,

Calibration and Preventive Maintenance Program, Escalation and

Investigation of Product Quality Issues, and Coordination of site

Management Reviews. Manage budgets and identify and implement cost

improvement initiatives to drive efficiencies without compromising

compliance. Lead company's governance team in assessing compliance, and

regulatory position and launching new and/or product changes. Lead FDA,

TUV, customer, Corporate, and Internal Audits in the operations. Lead

remediation and inspection readiness activities. Champion process

excellence and Kaizen events for continuous improvement.

Life Technologies, Carlsbad, CA

Director, Global Quality Systems & Compliance

Jan 2011 - Dec. 2012

As a global leader of the Quality Systems, I led the global groups that

included Quality Systems, Documentation and Change Control, Audit and

Compliance, Enterprise Systems Validation, New Product Introduction

Quality, and Supplier Quality Management

. Led the harmonization of Quality Systems, and Development and

Implementation of the Quality Policy, Quality Manual, Management

Reviews, CAPA, Design Control, Risk Management, and other key

systems

. Led the development and implementation of Audit Processes and the

alignment the of the manufacturing sites internal audit processes

i.e. preparing, and conducting audits, generating reports, and

mitigating gaps

. Led the compliance effort of the document management, document

change control system, and learning management system across all

manufacturing sites and regions. Ensured the changes were

implemented.

. Conduct Corporate Quality Systems Management Reviews. Trend and

review metrics for CAPAs, Non-Conformances, Audits and Complaints

with executive management and drive mitigation.

. Product Approval Committee member for new product introduction

within and outside of USA. Drive key decisions during product

development, design transfer, manufacturing, and post market

activities.

. Drove improvement in the New Supplier Qualification, and Existing

Supplier Evaluation Process, and developed and implemented the

Supplier Performance Metrics for Quality, Delivery, and Service

. Streamlined the complaint handling process for all regions globally.

Installed and led a global cross-functional team to perform the gap

in the current system, developed and implemented solutions.

. Implemented Statistical Process Control tools and processes on major

processes, improved yield by 25%

. Lead, Coach, and Mentor a team of 40 engineers including 7 Sr.

Managers

Boston Scientific, Valencia, CA

Director, Design Assurance and Validation Mar

2009 - Nov. 2010

. Streamlined the Design Assurance department of 23 that best suited

the need of the new product launches in fast paced environment.

Further, implemented programs that helped build quality into

products. These include development and implementation of Design

Control, Reliability Charter, software static analysis

process/tools, design/reliability analysis tools/methods, and some

of the product/software metrics. Evaluated, and implemented the Risk

Management Practices/ISO 14971 in Neuromod environment.

. Drove the implementation of issue management system (ClearQuest) and

the product requirement management system (ReqPro) that leaned the

product development process effort and enhanced compliance of

product development to design control requirements i.e. maintaining

traceability of outputs to inputs.

. Successfully helped launch Deep Brain Stimulation system and support

the next generation Spinal Cord Stimulation that is entering V&V

stage before the design transfer. Drove cost reduction effort of V&V

samples for new programs.

. Drove NC process as Board Member focusing on manufacturing and field

issue detection and prevention.

. Sponsored a multiple NCs and CAPAs that improved design and

manufacturing processes.

. Improved the internal design process and the supplier manufacturing

process by sponsoring a tier II CAPA triggered by a significant

field issue.

. Site champion for implementing in-process monitoring system driven

by the product/process performance.

. Standardized the Design Assurance Process that integrated the

product design output requirements with the manufacturing process

requirements/parameters.

Baxter Healthcare Inc., Round Lake, IL

Oct. 2001 - Mar 2009

Director, Corporate Reliability and Quality Engineering

June 2004 - Mar 2009

. Pioneered the implementation of Design for Reliability process, and

processes for Competitive Intelligence Benchmarking, and Baselining

products. Improved capabilities of test labs and currently, setting

up a test lab with an investment of $1.8 M. Implemented Design for

Six Sigma (DFSS) process. Implemented Business Excellence Model

driving organizational performance improvement through assessing

organizational efficiency and mitigating gaps by applying Malcolm

Baldrige Quality Criteria.

. Primary responsibilities included managing the multi-million dollar

budget and directing resources (multiple facilities) in quality and

reliability engineering, complaint (death/adverse events)

evaluation, leading CAPAs, product/process development, quality

planning, and product testing while delivering uncompromised

cGMP/QSR results.

. Improved compliance of I-pumps, nutritional, blood infusion, and

renal systems (drug, instrument, disposable) and complaint

evaluation labs by resolving issues related to FDA, TUV, and

internal audits.

. Implemented Management Review Process, Lean, and CAPA processes to

improve systems i.e. the timeliness of complaint evaluation, and

efficiency of complaint handling and drove several quality

initiatives across the company.

. Led enterprise wide development and implementation of Risk

Management Process (ISO 14971) requirements applicable during all

phases of product and process life cycles.

Baxter Healthcare Inc., Round Lake, IL

Senior Manager, Quality Engineering, Transfusion Therapies

Feb 2003 - June 2004

Primary responsibilities included managing Quality Assurance Department

of 14 senior engineers and engineering specialists supporting

development, launch, and support activities of 7 product lines. The

products include complex hardware, and disposables devices, and

therapeutics. Devices were designed for collection of whole blood,

blood components, and pathogenic inactivated blood components.

Developed 5-year strategic plan for future and sustaining engineering

programs. Led development of product requirements, quality plans,

system architectures, V&V plans, manufacturing plans, FMEAs, risk

analysis and led regular design reviews, manufacturing quality data

reviews, pre-launch, and launch data reviews. Assessed process

capabilities of key suppliers and inspection procedure to maintain

incoming part quality for products under development. Led CAPA team on

issue pertaining to whole blood sample dilution, and led problem

solving sessions to resolve the issue that resulted in $1.9 M savings.

Gave updates to FDA timely. Led quality activities during submission of

Premarket Approval and 510k of Pathogenic and Inactivation, and

Therapeutic Plasma Exchange products.

Baxter Healthcare Inc., LaChatre, France

Senior Manager, Quality Engineering, Transfusion Therapies

June 2002 - Feb. 2003

Implemented quality systems for Supplier Quality Management (APQP) in 3

plants - LaChatre (France), Lessines and Nivelles (Belgium),

Implemented Automated Statistical Process Control system to monitor

critical processes such as filling, E-Beam sterilization, bonding, etc.

Led CAPA team on issue pertaining to whole blood collection system.

Improved needle and tube manufacturing processes that resulted in $2 M

savings. Communicated progresses to regulatory authority (SANQUIN -

Holland) timely.

Baxter Healthcare Inc., Mountain Home, Arkansas

Senior Manager, Quality Engineering, Transfusion Therapies

Nov. 2001 - June 2002

Developed and implemented Supplier Quality Management System in 3

plants (Mountain Home, Puerto Rico, Dominic Republic). Supported P-

FMEA, SPC, DoE, IQ, OQ, PQ activities pertaining to the manufacturing

of a complex disposable device composed of a cassette, 3-lumen tubes,

and a centrifuge. Standardized Design and Manufacturing Control Tools,

and FRACAS system that enhanced product and process robustness. Offered

Green Belt Six Sigma (DMAIC) Certification training to the President,

Vice-Presidents, and Directors in the division. Developed and

implemented control plan, and Measurement System Analysis (gage R & R)

standard operating procedures in the division that includes plants.

Ford Motor Company, Dearborn, MI

Manager/ Member of Technical Staff, North American Car Line Division

Sept. 1999 - Oct. 2001

Primary responsibilities included recruiting, and mentoring members in

Quality Organization and offering expertise in quality disciplines.

Developed a marketing strategy that accelerated sales and promoted

Ford's brand among ethnic minorities in USA. Led supplier management,

Ford Product Development Process.

Senior Quality Engineer; Powertrain Division, Dunton, UK

June 1998 - Sept. 1999

Senior Quality Engineer; Powertrain Division, Dearborn, MI

May 1995 - June 1998

Quality Engineer; Powertrain Division, Dearborn, MI

May 1990 - May 1995

Led implementation of Reliability Plan, Accelerated Life Testing, HASS,

HALT, MTBF, MTTR, DoE, Statistical Methods, QFD, FMEA, FMECA, PRAT,

FTA, Problem Solving, DVP&R, Robust Design pertaining to

diesel/gasoline engine, transmission, body, and various

electromechanical components.

Key Accomplishments:

> 2 time recipient of VIP and CAPA awards at BSC

> Drove process improvement strategy as being the NC and CAPA board

member at BSC

> Assured FDA and TUV readiness and collaborated with teams for

successful inspections of complaint evaluation labs, death/adverse

event investigation process, CAPAs, etc.

> Developed and implemented master validation package for lab

equipment, software, computer systems, and processes.

> Developed integrated processes for D-FMEA, P-FMEA, control plan,

statistical process control, measurement system analysis, and

supplier quality management system.

> Implemented above processes in 7 large manufacturing plants in

USA, Europe, & Dominic Republic. Selection of key suppliers and

control of manufacturing processes to maintain desired part

quality are governed by these processes.

> Led multiple critical CAPAs that resulted in cumulative savings of

$ 3.9M and addressed regulatory issues.

> Implemented automated statistical process control system in 5

manufacturing plants monitoring critical filling, sterilization,

bonding, and assembly operations.

> Championed multiple important six sigma (DMAIC) projects that

include the project that resulted in improvement of efficiency and

timeliness of death/adverse event complaint evaluation by 40%.

> Created Corporate Reliability Engineering Organization - Tasks

included creating organization charter, budgeting, hiring, and

developing talents, and aligning staff to support critical quality

& design efforts.

> Established the infrastructure for Design for Reliability for

Hardware, Software, and Disposables and instrumental in developing

and implementing Product Development Process (Design Control).

> Implemented enterprise wide Quality Systems that includes Risk

Management Process i.e. ISO 14971 managing risk during product and

process life cycle.

> Established Organizational Strategic Planning Process driven by

the Malcolm Baldrige Quality Criteria that propelled organization

performance.

Honors and Recognition

> Edwards Medal Committee Member, ASQ

> Judged International Team Excellence Award Event hosted by ASQ,

2007 & 2009

> Examiner for "The Lincoln Award for Performance Excellence" in the

State of Illinois, 2007

> Recipient of Regulatory Affair Executive Leadership Development

Program, Kellogg Business School

> Two-time recipient of Key to Success awards at Baxter

> Committee member of AAMI/EM, Electromagnetic Compatibility

> Certified investigator, and CAPA owner at Baxter

> Vice-chair, G-11 committee, Society of Automotive Engineers, 2000

- 2002

> President, Society of Reliability Engineers, Michigan, 1995 - 1998

> Two-time recipient of Customer Driven Quality Awards in the Ford

Motor Company

> Co-chaired in Reliability Maintainability and Supportability

Logistics conferences organized by SAE, 1996 and 1997

> Received training in Business Leadership conducted for fast track

managers

> Received training in Dale Carnegie techniques

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