Manager Quality

EUGEN DINU

Cherry Hill, NJ *****

Home: 856-***-****

Cell: 215-***-****

email: ac150y@r.postjobfree.com

ENGINEERING MANUFACTURING QUALITY OPERATIONS EXECUTIVE

* Leadership * Medical Device Manufacturing * FDA QSR cGMP ISO 13485 * Design Control

* Validation Management * Sterile Manufacturing/Packaging * Management of multi-site operations

* International experience in Europe and Asia * Effective verbal and written communications

Results-driven operating executive with over 30 years of progressive experience in manufacturing, research and development, and engineering management in FDA regulated environments. A highly effective professional possessing broad experience in the medical device and other industries demonstrating a strong ability for the management of technical and financial resources, resolution of complex technical problems and appreciation of the commercial aspects of business. A strategic thinker with proven leadership abilities of multi-cultural teams in changing business environments. An experienced coach and mentor with demonstrated results in developing the talent of individuals and forming successful specialist teams. An entrepreneur combining modern engineering, design and manufacturing philosophies and systematic approaches to consistently deliver strong operating and financial results.

EXPERT QUALIFICATIONS

* Certified Lean Manufacturing Six Sigma Black Belt

* Quality Assurance, ISO 9001-2015, 13485-2016 & CE

* Certified Quality Manager CQM

* Project and Program Management - Certified Project Management Professional PMP

* Long Range Strategic Planning

* Operations and General Management

* Medical Device Manufacturing cGMP & FDA QSR

* Financial Oversight - Profit and Loss (P&L) Responsibility

* Aseptic Manufacturing, Class 100 Clean Room, Lyophilization

* Research & Development and Engineering Management

* FDA Class II and Class III implantable devices

* Data-based analysis and decision making

* Training, Development & Team Building; leading cross-functional teams

* Resources & Personnel Management

* Fluent in Romanian (native), French, conversational in German

EDUCATION

* M.B.A., Rutgers University, NJ - Major in Business Management, Minor in International Business

* M.Sc. Mechanical Engineering, Polytechnics University, Bucharest, Romania - Major in Boilers and Pressure Vessels

PROFESSIONAL HISTORY

PULSE TECHNOLOGIES, INC. Quakertown, PA

2017 – Present DIRECTOR OF QUALITY ASSURANCE (Consulting Assignment)

Reporting to the CEO on an interim basis, in charge of the Quality System and Quality Strategy for company’s product portfolio, ensuring that short and long range quality strategy, plans, goals, annual operating plans and budgets are aligned with the business. Serve as the “Management Representative” as prescribed in the Quality System Regulation (QSR 21 CFR 820), ISO 13485:2016, and ISO 9001-2015. Create and implement process improvement programs and projects. Lead and Manage a top-performing team of Quality Engineers, and Inspection personnel; mentor, train, and coach. Develop in-process and finished product inspection data using SPC, providing trend analysis and improvement opportunities. Ensure quality product is available to customer through new process design, design review, engineering, customer/vendor relations, manufacturing quality, cost reduction, inspection, environmental monitoring, calibration, training, product serialization, customer complaint management and MDRs. Develop and implement systems that monitor the Quality Management System (QMS) and report to management weekly on audit results, corrective actions, and performance. Follow up and support of employees and teams to ensure corrective actions are initiated, implemented, and measured for effectiveness. Oversee customer complaints, resolve complaints and returned products investigations, analysis, and corrective actions.

•Performed gap analysis and ensured QMS readiness for transition to ISO 13485-2016, ISO 2001-2015, and AS9100 Rev D; Played a major role in getting the company certified to the new version of the ISO 13485 standard

•Built world class quality organization which attracted clients over more established and larger competitors. Collaborated with clients to consistently meet or exceed performance requirements and expectations.

•Created policies related to quality for the organization while assessing appropriate levels of risk associated with specific policy requirements. Improved quality systems by reducing complexity and increasing effectiveness.

•Proactively identified and alerted executive management of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.

•Integrated the SPC computer software platform with the various automated measuring devices’ (Keyence, Smart Scopes, CMMs, etc.) output to increase efficiency and eliminate reporting errors.

MERCER GASKET & SHIM, Bellmawr, NJ

2016 – 2017 DIRECTOR OF OPERATIONS (Consulting Assignment)

Hired by the company owner to increase efficiency, reduce costs, increase customer base and market share for this 80,000 sf. specialty gasket manufacturing facility. Site-level responsibility for safety, quality, delivery and cost. Direct supervision of 6 managers responsible for Manufacturing, Quality, Supply Chain, Manufacturing Engineering, Environmental/Health/Safety, and Administration. Total indirect responsibility for 50 employees.

•Maintained 98+% on-time delivery through robust supplier selection and management, visible and data-driven milestone/performance evaluation and direct ownership within operational work cells and teams.

•Achieved 3 consecutive quarter-over-quarter improvements in profit above baseline forecast as well as multi improvements in Sales per Employee and Sales per Square Feet productivity metrics

•Led Lean Daily Management System via Gemba walks to identify and resolve constraints, ensure continuous product flow, foster communication/teamwork and enable on-time delivery of quality products

•Implemented robust CAPA process to ensure root causes of non-conformances are identified via 5-Why and/or Ishikawa diagrams and corrective actions are implemented

•Ensured a safe work environment through monthly process audits including 5S and Job Hazard Analyses.

TRIANGLE TUBE, Blackwood, NJ

2014 – 2016 SENIOR DIRECTOR OF TECHNICAL SERVICES & QUALITY

Responsible for establishing and executing the overall technical strategy for North America in support of ACV International Group’s business plan. Lead, plan, organize and direct new product introduction and certification activities, as well as Tech Support, R&D and Engineering, Quality, Documentation, and Warranty Management in support of manufacturing and distribution of European company’s residential and commercial products. Responsible for managing, supporting, and providing direction and leadership to project teams and functional leaders as well as taking a hands-on approach in the execution of all Technical Services duties. Established and maintained positive and productive relationships with domestic and international technical and commercial partners, as well as ensured that technical capabilities and performance, product documentation and certifications meet or exceed all customer and industry requirements for quality, performance, compliance, and cost. Responsibilities include:

•Oversight for all technical services in US and Canada for residential and commercial high efficiency boilers and water heating products; established and implemented best practices within the function; realized over $1.5M/ year in savings

•Support to European corporate R&D and Operations for the advancement of products and services and product launches in the NA market; introduced 2 new product lines and a line extension increasing sales revenue by 17%

•Develop technical specifications for the NA market and interface with R&D and operations in Europe for quality assurance, performance improvements, and regulatory certification of all products; troubleshoot and improve product design and functionality for quality, cost, and compliance;

•Provide management and oversight for customer and technical sales management for the advancement of products and services; provide oversight and management of the technical marketing and written documentation for the NA market; manage warranties in North America

•Conduct quality audits, resolve discrepancies and problems, and verify corrective action relating to product quality and conformance issues; report trends and concerns to European corporate Quality

•Ensure the achievement of annual objectives including project timelines, financial performance, and product performance

WASTEQUIP LLC, Erial, NJ

2012 – 2013 DIRECTOR OF ENGINEERING AND QUALITY

Managed several functional areas within $85 million operating division that includes leadership of 11 direct and 24 indirect reports within R&D and New Product/Process Development, Sustaining Engineering, Product Support, Manufacturing Engineering, Cost Estimating, Tooling Design, Quality Assurance, and Process Excellence. Manage products and processes for the entire lifecycle, control capital equipment budgets.

•Performed successful benchmarking project comparing flagship product line to main competition and used lessons learned to design world-class new compaction product

•Saved $650,000 annually by redesigning the compaction product line and manufacturing process •Established Lean Manufacturing practices utilizing cell manufacturing (Kan Ban) and point-of-use inventories resulting in 18% inventory reduction and 38% increase in on-time delivery performance.

•Led strategic engineering planning for the development of new production lines and transfer of multiple product lines following divisional consolidation; streamlined product offering by combining best product designs and features

•Established Lean Program for Operational Excellence focusing on continuous process improvement and reduction of waste; conducted periodic Kaizen events at all sites across the US driving process quality and cycle time improvements; established a process to systematically utilize root cause analysis and develop preventive counter measures

•Developed Quality Management System with Quality Manuals and Operating procedures/policies

•Led culture change initiative that implemented Lean and Six Sigma, engaging employees at all levels •Developed Operational Metrics emphasizing Key Performance Indicators and Voice of the Customer and aligned division KPIs with corporate goals and expectations

•Restructured Engineering department across the five manufacturing plants to better respond to customer needs in local markets; led team in meeting/exceeding goals on metrics that included on-time delivery, customer satisfaction, safety, operational performance, and profitability.

•Developed and leveraged best practices across the Technical Products Division and rest of Wastequip

•Developed strong working relationships across functional groups, implemented technical training and support programs; secured $56K training grant from NJ Department of Labor for Six Sigma training of all plant employees

INTEGRA LIFESCIENCES, Plainsboro, NJ

2007 – 2011 ENGINEERING MANAGER

Responsible for management of the Engineering group in support of all manufacturing operations and product development activities in NJ and sister plant in Puerto Rico. Manage activities of planning and development of strategic projects and initiatives aimed at current and future developments in manufacturing, processes, and new product introduction. Manage group of Engineers to assess feasibility of and develop new manufacturing processes for new and existing products, lead development, review, and implementation of new manufacturing processes and equipment, lead and coordinate development of specifications for new manufacturing and testing equipment, coordinate verification and validation of equipment and processes. Manage activities of planning and development for equipment and processes to meet the demands of manufacturing operations and new product research and development.

•Delivered over $3.5 million in savings in a 4-year period by focusing efforts on productivity increases, cost reduction, scrap reduction and elimination, implementation of Lean Manufacturing techniques and Six Sigma quality processes. Managed continuous improvement efforts in manufacturing and engineering operations, implemented SPC control system. Implemented advanced manufacturing systems which reduced labor, increased quality, and boosted efficiency levels.

•Introduced several new technologies and products and increased overall sales by 27%. Owned Design Control process, interface with corporate R&D, Voice of Customer process, and Manufacturing process. Implemented risk analysis and problem solving skills to identify potential issues, assess their impact and develop and implement mitigation and resolution.

Amplified productivity 12% per year and accelerated first-pass yields from 86% to 92% through new process, automation, and tooling improvements.

•Established standards and structure for new product development efforts. Implemented cross-functional teams that evaluated/conducted business risk analysis, proposal development, and manufacturability assessment. Ensured Lean Product Development and Design Control processes and procedures. Completed product development for successful 510(k) registration and launch of five new products in both US and ROW markets. Reduced product development cycle for new products from 12 to 8 months on average.

•Planed and administered efficient resource utilization (material and personnel) to achieve department, plant, and corporate goals. Customized and integrated automated machinery that increased productivity threefold and paid for itself within the first year.

PREMIER MEDICAL MANUFACTURING, Philadelphia, PA

2002 – 2006 GENERAL MANAGER

Top level executive with overall responsibility for the coordination of all manufacturing division’s departments, including the quality system, production, new product design and development, sales, and administration. Member of corporate Executive Committee and major contributor in capitalizing market opportunities, mergers and acquisitions, new product lines implementation into manufacturing. Provide leadership to guide company through the strategic planning and practical implementation of initiatives aimed at increasing manufacturing efficiency, improving process transfer practices, creating a lean and flexible customer-focused manufacturing organization, improving product quality and reliability, reducing time to market, eliminating redundancy and enhancing vendor management practices. Develop long term manufacturing strategies, provide tactical leadership to meet contract (private label) manufacturing commitments, manage cost reduction programs, develop and administer capital and expense budgets. Liaise with all appropriate corporate groups to ensure success of corporate goals. Direct all manufacturing activities to ensure a compliant, safe, efficient, high quality operation. Lead process re-engineering to enhance productivity and increase efficiencies. Provide technical expertise and managerial guidance in the areas of technology transfer, project management, quality assurance, process development and scale-up, validation, manufacturing management, equipment engineering, facilities design, supplier development, contract management, and medical device design and development. Interface with federal and local governmental agencies for medical device and environmental safety compliance monitoring.

•Increased overall sales by 24% by diversifying product offering and process capabilities, addition of new product lines, while reducing costs by 12 percentage points through automation and robotics, changing supply methodologies, competitive bidding, revising product specifications, and securing alternative vendors

•Grew contract manufacturing (private label) sales by 45% within a two year period and maintained increased level by effective customer management and consistent good quality and on-time delivery

•Developed and implemented strategies for the technical transfer of four acquired companies with complimenting products, three of which are medical device manufacturers. Coordinated equipment, process, and product validation, verification, and transfer, including equipment for sterile packaged products

•Identified, hired, motivated, and coached multi-national management team to develop and grow the engineering and purchasing departments, inventory management, and customer service

•Orchestrated quarterly sales and marketing events, successfully inspiring sales group to secure consistent placements and reorders on all current and new product lines to existing customers as well as growing account base with placements to new customers

•Established standards and structure for new product development efforts. Implemented cross-functional teams that evaluated/conducted business risk analysis, proposal development, and manufacturability. Reduced product development cycle on new products from 10 to 6 months

•Forged strategic alliances with overseas suppliers of tooling and components, significantly reducing manufacturing costs

•Successfully introduced tens of innovative, patented products, sustaining market share dominance in several segments

KEYSTONE INDUSTRIES, Cherry Hill, NJ

1999 – 2001 VICE PRESIDENT ENGINEERING

Operating Executive with full responsibility for planning, development, engineering management and turnaround of this 30+ employees manufacturing division of $40M company. Deeply involved with long range planning with senior management. Established the overall objectives and initiatives of the engineering department. Proactively managed the daily design, development, and testing of all aspects of mechanical and electrical components, equipment, and machinery developed. Spearheaded complete manufacturing automation. Managed staff and had full responsibility for project engineering, manufacturing engineering, new product development, testing and validation. Worked closely with Sales and Marketing and developed key programs and customers.

•Developed strategy with Marketing and captured 13.3% of the market for vacuum forming machines for the dental industry with the design, development, and launch of patented new machine

•Created a strategic team alliance with a complementary corporation, resulting in the award of $1.2M in total orders of fluoride treatment trays

•Implemented strategic business alliance with a synergistic foreign company, leading to the development of several electronic equipment products generating $120K the first year

•Customized and integrated automated machinery for disposable product packaging that increased productivity threefold and paid for itself within the first year

•Directed R&D plans; revived product line through performance enhancements, resulting in doubling sales from $150K to $300K in 2000

•Integrated manufacture and design engineering departments, creating a system designed for concurrent engineering. Implemented SolidWorks software as part of the system and significantly impacted design and manufacturing accuracy

•Restructured and streamlined department procedures to meet ISO 9000 certification

•Credited with guiding successful turnaround of faltering division resulting in a continuous improvement environment, increased quality, efficient delivery system, restored customer confidence and strong positioning for long term growth

GARLOCK VALVES AND INDUSTRIAL PLASTICS, Camden, NJ

1995 – 1999 ENGINEERING MANAGER

Promoted from project engineer to manage engineering efforts of $25M company; oversee Engineering and R&D budget of $2M annually.

•Efficiently and effectively developed and managed all resources and personnel assigned to the engineering department; developed job descriptions and monthly objectives for all personnel; developed complete departmental budget analysis

•Developed project descriptions and completion schedules for all projects assigned to the department; developed and designed quality assurance testing models for analysis of raw materials, materials in process, and finished products

•Established close collaboration with Sales and Marketing to determine market requirements on new product features and performance, and with Production for successful prototyping, testing and manufacturing of new products; Presented corporate management with project proposals, budgets, detailed work progress reports, and new product introduction results

•Performed Applications Engineering: stress calculations and analysis, flow calculations, product recommendation for different conditions of media and pressure-temperature, actuation; Troubleshooted field problems and supported customers, Sales representatives and Distributors

•Managed and coordinated creation of Bills of Materials and production routings in ERP system

•Chaired the ISO 9000 Internal Audit Committee

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