Summary Profile

Innovative and outcome-focused leader with uncompromising commitment to achieving exceptional results in highly competitive environments that demand continuous improvement. Offer senior leadership experience in driving product, process and service improvements while building mutual relationships with international suppliers and vendors. Consistent record of increasing production, reducing operational cost and improving product quality by leveraging world-class manufacturing concepts (Lean Manufacturing and Six Sigma).

Key Strengths

Operational and Strategic Planning

Global Marketplace Operations

Regulatory Compliance (HIPAA, OSHA, EH&S, FDA,FCC and FTC)

Quality Assurance

Process Reengineering / Optimization

Budget Management /Cost Reduction Practices

Project Leadership

Professional Experience

Siemens Hearing Instruments Piscataway, NJ

Head, North American Manufacturing Operations November 2015-Present

Senior Director of Quality Assurance and Regulatory Affairs Oct 2008-November 2015

Director of Quality Assurance and Regulatory Affairs Aug 2007-Oct 2008

Provide strategic leadership and direction to 11 direct and 150 indirect reports, along with the responsibility for managing annual budget in excess of $10M. Administer quality assurance and regulatory affairs for all hearing products generated by Siemens within North and South American regions. Responsible for all manufacturing, service and distribution operations for products sold within North America. Established and maintain an open line of communication with international supplier base in Singapore, Germany, Thailand, Indonesia and China. Strictly enforce compliance with FDA and FTC regulations. Function as EH&S executive sponsor designated to perform duties relating to environmental, workers compensation, OSHA and compliance. Serve as Business Continuity Officer and HIPAA compliance officer with full responsibility of ensuring strict compliance with all HIPAA requirements. Additionally responsible for all manufacturing operations within North America product functions.

Led successful FDA inspections at multiple sites within North American. Co-lead FDA Inspections in Singapore, Germany and China. Also facilitated several successful inspections with Health Canada.

Formulated and led the strategic implementation of a new inventory management system that greatly reduced inventory carrying costs by 50% or equivalent to $18M.

Instrumental for the planning and implementation of facility renovations valued at $7M.

Strategically devised business continuity plan.

Organized, planned and executed business consolidation which produced significant savings in direct/indirect labor as well as associated facility and operational costs.

Played an integral role for driving quality improvements within both new and services products.

Stryker Orthopaedic Mahwah, NJ

Operations Manager / Advanced Operations Jan 2005-Jul 2007

Rendered functional oversight to 14 direct reports; coordinated all actions relating to project monitoring, which include new project management tools, records of expenditure, weekly progress reports and staff conferences to communicate current projects status to senior leadership. Displayed proficiency in coordinating all incoming raw material procurement in adherence to project scope, price and availability. Leveraged strong analytical capabilities in evaluating expenditures, financial and operations reports to determine requirements for increasing profits, including need for amplifying capacity of core products, maximizing product portfolio size range and optimizing product pricing. Actively participated in D.O.E., mock runs, validations, FDA, 510K and GMPs.

Generated 75% increase in operational capacity by streamlining traditional production practices.

Dramatically improved production output in excess of $11M for the last two calendar years through the successful implementation of Six Sigma tools to facilitate process improvement initiatives.

Gained recognition for successfully planning and coordinating supply chain activities in collaboration with global partners; expertly handled negotiation with 3rdparty contracts in OSP and alternate sourcing vendors.

Trimmed down more than $1M in operational outlays through successful implementation of Lean inventory practices.

Ford Motor Company Edison, NJ

Vehicle Line Quality Manager (Ranger/Mazda / F150)/ Executive Operating Committee 1997-2004

Training Manager 1996-1997

Production Superintendent 1992-1996

Manufacturing and Planning Engineer 1991-1992

Q1 Coordinator 1990-1991

Production Supervisor 1989-1990

Fostered authentic leadership image and motivated 15direct salary and 400+ UAW hourly toward the achievement of strategic goals. Facilitated daily operations and in compliance with applicable regulatory codes, particularly OSHA, EPA, FBI, ISO9000, ISO14000 and QS9000 mandates. Displayed hands-on management style in leading subordinate managers and supervisors as well as hourly employees. Transformed existing staff into a tightly focused support structure with unyielding focus to achieve established objectives and stringent schedules.

Spearheaded the implementation of a quality operating system that yielded considerable warranty cost savings by 1.2M savings for FY2003.

Orchestrated the deployment of two quality-related "best practices" that was later adopted as the company’s standard operating procedures (Customer Feedback Cards and Edison FCPA process).

Devised aggressive business plans that drove 4% reduction in direct labor costs while saving the company $250K annually for the last 5 years; handled $5M direct labor payroll for calendar year 2003.

Exhibited proficiency in managing plant indirect materials with $10M (per 2003) annual budget; formulated strategic initiatives to eradicate various wastes that resulted in 10% reduction in indirect materials usage yearly.

Successfully lead the planning and execution of key quality initiatives which were instrumental in achieving 2 J.D. Power awards for model year 2000 (Mazda B-series, Spring 2000 and Ranger, Fall 2000), as well as 2 J.D. Power awards for model year 2003 (Mazda B-series, Spring 2003 and Ranger, Fall 2003).

Handled the transitioning of two-shift to a one-shift production organization that greatly improved quality output; generated 39% improvement in warranty expenditure along with frequency repair in 2002.

Designated by executive management to assume the role of a plant closure transition team leader responsible for plant decommission planning, people transfer (at 800 hourly/100 salary), union partnering and community relations regarding all aspects of shutting down operations. Successfully migrated all personnel from plant assignment and developed last few months on units without affecting production quality.

Chaired the Ford Motor Company Corporate Citizenship Committee from 1999 to 2004.

Garnered Ford Motor Company Volunteer of the Year Awards in 1999 and 2001 for successfully leading plant corporate.

Education

Postgraduate Business Administration Degree University of Liverpool, Liverpool, UK (2007)

Master of Science in Management and Technology Rensselaer Polytechnic Institute, Troy NY (2004)

Bachelor of Science in Management Science Kean University, Union NJ (1991)

Professional Development

Certificate degree in Supply Chain Management Rutgers University, New Brunswick NJ (2006)

Lean Learning Academy(2003)

Six Sigma Black Belt Champion

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