Quality Assurance Continuous Improvement

STEVEN A. DUVAL

978-***-**** (cell)

***********@*******.***

Newport Maine

Summary

Dynamic and results-driven Engineer Manager with over 20 years of experience overseeing the efficient operation of manufacturing facilities. Skilled in leading and managing cross-functional teams, implementing Lean management principles, and driving continuous improvement initiatives. Proven track record in improving operational efficiency, reducing scrap ratio, and ensuring compliance with quality systems. Adept at developing and communicating long-term engineering business strategies to optimize manufacturing operations. Proficient in coordinating maintenance, tooling, molding, and engineering departments to achieve cost efficiencies and enhance overall productivity.

Professional Experience

Oatey Inc. – Manufacturing Engineer Manager

2/01/22 – Present

Lead and oversee maintenance, tooling, molding, and engineering operations to optimize manufacturing efficiency and product quality.

Implement and sustain Total Productive Maintenance (TPM), Process Safety Management (PSM), 6S, and Lean methodologies to improve plant performance and workplace organization.

Manage P&L for all plant operations and departments, ensuring consistent profitability through effective cost management and operational strategies.

Develop and execute long- and short-term engineering and business strategies to achieve organizational objectives.

Collaborate with cross-functional teams, including Quality Assurance, Marketing, R&D, and Sales, to align production goals with business demands and customer expectations.

Ensure compliance with FDA regulations, cGMP, QS/ISO 9001, ISO 13485, and other applicable industry standards.

Drive continuous improvement initiatives, including Lean Process Design, Demand Flow Technology, and 6S workplace philosophy, to enhance value streams and efficiency.

Review and approve capital expenditures for new equipment and upgrades, ensuring operational continuity and advancements.

Foster employee engagement and development by setting clear expectations, assessing performance, and providing coaching and feedback to improve skillsets and leadership capabilities.

Achieved measurable improvements in operational metrics, quality assurance, and customer satisfaction.

Biomedical Polymers Inc. – GM/Plant Manager

11/28/16 – 2/01/22

Directed all plant operations, managing over 30 injection molding machines and packaging processes to meet production targets and maintain high-quality standards.

Championed Lean Manufacturing principles, including 6S, Kaizen events, and Demand Flow Technology, leading to operational efficiency improvements from 85% to 97%.

Reduced scrap rates from 10% to 1.5% through systematic process optimization and defect reduction strategies.

Supervised and developed seven senior managers, overseeing Finance, Engineering, Maintenance, and Tooling departments while driving cross-departmental collaboration.

Established and led weekly senior management meetings to address and resolve operational challenges, align strategies, and review progress toward goals.

Maintained adherence to FDA, ISO 13485, QS/ISO 9001, and customer-specific quality standards, achieving compliance with all relevant regulations and audits.

Oversaw capital investments, budgeting, and resource allocation to enhance equipment capabilities and operational efficiency.

Developed and implemented safety programs, achieving a six-year accident-free record and ensuring employee adherence to health and safety protocols.

Delivered strong P&L performance by executing cost-saving measures, process improvements, and revenue-driving initiatives.

SMC Ltd. – Technical Operations Manager

3/2011 – 10/18/16

Managed technical operations across three facilities, optimizing production for 75 injection molding machines to achieve 96% operational efficiency and a 25% increase in machine uptime.

Implemented RJG and eDART process monitoring systems to ensure precise control and adherence to product quality specifications.

Spearheaded Lean initiatives, including monthly Kaizen events and 6S training, to streamline workflows and reduce waste across operations.

Directed a team of 120 professionals, fostering collaboration among engineers, program managers, and production staff to achieve organizational objectives.

Improved profitability through mold redesign, process enhancements, and equipment evaluations, achieving significant cost reductions.

Collaborated with R&D, Quality Assurance, and other departments to launch new products and enhance manufacturing processes.

Maintained FDA compliance for Class 7 and Class 8 cleanrooms while ensuring QS/ISO 9000 certification.

Reduced scrap from 25% to 4% within two years through process control and quality assurance measures.

Nypro Inc. – Operations Manager

1/2006 – 3/2011

Supervised operations for 70 injection molding machines, leading production teams to meet stringent quality and efficiency standards.

Achieved significant improvements in production flow, cost reduction, and quality through Lean Six Sigma projects and continuous improvement initiatives.

Led a team of 175 direct and indirect employees, spanning seven shifts, to maintain seamless operations and achieve corporate objectives.

Liaised with customers, engineers, and quality teams to ensure product specifications and satisfaction were consistently met.

Increased overall machine efficiency by 25% through the implementation of robust maintenance and process optimization programs.

Managed budget reviews and provided P&L accountability, ensuring resource alignment with operational goals.

Education

Nypro University/Fitchburg State University – BS Industrial Engineering

Certifications

Master Molder RJG I & II

Six Sigma Green Belt

QS/ISO Certified

Dale Carnegie Training: Leadership & Management, Coaching for Top Performance

Skills

Engineering & Strategy Development: Expertise in creating and executing business strategies aligned with organizational goals.

Lean Manufacturing: Skilled in 6S, Demand Flow Technology, and continuous improvement.

Operations Management: Proven ability to manage plant operations, P&L, and cross-departmental functions.

Regulatory Compliance: Proficient in FDA, cGMP, ISO 9001, and ISO 13485 standards.

Process Optimization: Extensive experience in reducing waste, improving efficiency, and enhancing quality through Lean and Six Sigma principles.

Team Leadership: Strong track record of managing and developing diverse teams to achieve high performance.

Safety & Risk Management: Expertise in implementing safety programs and maintaining compliance with environmental health standards.

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