Post Job Free
Sign in

Quality Assurance Medical Device

Location:
Thiells, NY
Posted:
June 18, 2014

Contact this candidate

Resume:

KUNWAR HARRICHARRAN

** ********** ****

STONY POINT, NY 10980

614-***-****, 845-***-****

acel2b@r.postjobfree.com

EXECUTIVE SUMMARY

VP with over 20 years of hands on experience utilizing Lean Principles to drive change, increase productivity and

customer satisfaction, resulting in organizational excellence for small, medium, and large enterprises. A dependable,

respected coach and mentor with a rich history of building high performing teams.

Expertise include Strategic Sourcing, Quality Assurance and Compliance, and Engineering in Medical Device,

Government, Automotive, Aerospace, Sensors, and Control systems industries.

In depth knowledge of regulatory compliance for FDA, ISO 13485, cGMP, cGLP, AS9100C, IPC, MIL

STD,ITAR, FAR, VPP, ISO 9001, ISO 2020, UL, CSA.

Process expert in Surface Mount Technology, Wave soldering, and PCBA.

Expert application of TQM, Six Sigma, Lean, Value Stream Mapping, 6S, Design for Manufacturability.

CAREER HISTORY & ACCOMPLISHMENTS

Crestron Electronics – Rockliegh, NJ

2013 Present

VP of Global Supply Chain, and Quality Assurance and compliance (12 months contract)

• Developed and Implemented Crestron’s first Corporate Quality Strategy.

• Responsible for setting and managing corporate KPI including Global Supplier Performance and Strategic Supplier

Selection and Development, and Product Performance Reliability.

• Recruited, trained, and lead a high performing Quality Assurance Team to realize domestic and international quality

goals.

• Train teams to learn and apply proven quality methodologies leading to a positive trend in customer satisfaction for

lighting controls, automated shading solutions, and audio visual portfolio of products. Out Of Box (OBF) failures

reduced from 12% to 8% and trending down.

• Define and manage quality goals for $500 M Contract Manufacturers supply chain,

• Responsible for Crestron’s compliance to required quality standards.

• Created and implemented New Product Introduction process and procedures with a heavy emphasis on early supply

chain engagement.

• Introduced APQP, PPAP, PFMEA, FMEA, DFX methodologies.

Battelle Advanced Manufacturing Operations – Columbus, OH

2008 2013

Vice President of Operations

• Developed and lead a high performing team to manage a $650 M, production portfolio for multiple Battelle’s

business units (Medical Device, Aerospace, Automotive, Sensors) while delivering all products on time and under

budget with healthy gross margin.

• Responsible for site operations (domestic and international), regulatory compliance, safety, supply chain,

manufacturing engineering, production, delivery, quality, continuous improvement, cost reductions, efficiency

gains..

• Transitioned a service based approach to a production based strategy generating $1 Billion of production revenue

over 5 years.

• Delivered Battelle’s Medical Device solutions on time while meeting all cost, delivery, and quality targets for a

$200 Million Health and Life Science programs.

• Successfully filed and gained FDA approval for Medical Device and Products designed and developed for

Battelle’s Health and Life science customers.

• Train teams to learn and apply lean principles across functional teams to realize significant efficiency and

productivity gains for commercial and defense production, leading to multimillion dollars cost reductions.

• Transitioned mature products to global supply chain partners in several international locations including China,

India, Mexico, Republic of Georgia, and other European locations.

• Developed and implemented global operations strategy allowing organization to maintain competitive edge through

productivity and efficiency gains.

• Applied TQM and Six Sigma methodologies to drive improvements for CTR (Continuous Technology

Refreshment), a service life extension program for the Army and Air force Rotary Fleet, C 130

instrumentation panel, and F 16 HUDS resulting in multi million dollar production awards.

• Managed manufacturing operation staff domestically and internationally.

• Applied Design for Manufacturing (DFM) and Flexible NPI prototyping methods successfully for over 40

different products originating from multiple Battelle managed national laboratories.

• On time and below budget production of a R&D 100 award winning Liquid Scanner (LS10) for hazard detection at

airports.

Lutron Electronics – Coopersburg, PA

2000 2008

Director of Corporate Quality and Compliance

• Managed global quality assurance teams in the United States, St. Kitts, Mexico, Puerto Rico, and China locations.

• Analyzed customer feedback, product reliability data, industry needs, and developed a company strategy to ensure

maximum efficiency.

• Instituted lean principles across the global enterprise such as Value Stream Mapping, Six sigma techniques and

certification programs.

• Consistently utilized conflict management and team building skills, resulting in increased organizational

efficiency.

• Recognized as a self motivated leader with the ability to teach and train others as well as identify, analyze and

solve multiple problems quickly and efficiently.

• Set continuous improvement goals across all locations and hired a lean professional to champion each site.

Rockwell Automation – Mayfield Heights, OH 1994 2000

KUNWAR HARRICHARRAN

41 WILDERNESS 4896

STONY POINT, NY 10980

614-***-****, 845-***-****

acel2b@r.postjobfree.com

New Product Introduction (NPI) Manager

• Managed a design to production transition team which included 40 members of electrical, mechanical, component,

and Industrial engineers.

• Reduced product introduction cycle from 18 months to 12 months with a 35% efficiency gain.

• Standardized product development design policies which resulted in $1 Million cost avoidance, increased time to

market by 35%, and reduced iterations by 50%.

• Developed a ‘Technology Roadmap’ to guide design and product engineers with respect of emerging technologies

for cost reduction, increased space utilization, speed performance, protection, and security.

• Demonstrated sharp leadership skills and applied strong organization in coordinating and working on projects.

Siemens Automation – Johnston City, TN 1989 1994

Design and Development Engineer

EDUCATION

Masters of Science in Electrical Engineering (M.S.E.E.): University of Tennessee, TN (24/30 credits)

Bachelor of Science in Electrical Engineering (B.S.E.E.): University of South Alabama, AL

Battelle Executive Leadership Program

US Export Controls & Defense Trade Controls: The Export Compliance Institute

Defense Acquisition Management: Defense Acquisition University

CERTIFICATIONS AND MEMBERSHIPS

Six Sigma

Lean Principles, Value Stream Mapping

Active DOD SECRET Clearance

Battelle’s Diversity Council Co chair

ISO 9001, ISO 13485, AS9100, cGLP, and cGMP

Center for Design and Manufacturing Innovation (CDME) Advisory Board

Expert Panel Member – National Network for Manufacturing Innovation (NNMI)

Ohio, Indiana, West Virginia TPE (The partnership for excellence) Board of Trustees

Commencement speaker, Gulf Coast State College, 2013



Contact this candidate