Thomas F. Bregani

*** ****** **. **********, ** *3047 (c) 603-***-**** acxp4c@r.postjobfree.com

Professional Profile

Experienced manager with extensive background in quality assurance, operations, new product development, project management, and regulatory affairs. Recognized for ability to develop and establish proactive, interrelated business processes and for ensuring that critical operational decisions are made at the front end of a business opportunity. Skilled at creating vision and charters to help cross-functional teams work logically and effectively.

Career Highlights

Achieved Quality Management System (QMS) certification at 6 companies, on-time and under budget. (Termiflex, Luxtec, HyperMed, Lampin, HaA Medical, Boston Engineering); ensured recertification at 2 others (Radius Product Development, Johnson Precision)

Designed and chaired a weekly Project Review Board wherein project and account managers present metrics and status to the executive team resulting in proactive addressing of issues (Boston Engineering)

Recognized in “Turnaround Company” award for departmental contribution to revenue growth of $400K and capability enhancements. (Radius)

Improved outgoing quality level of cart-based medical diagnostic equipment by 75% by designing and implementing a system of production test, inspection, and audit controls. (HyperMed)

Increased workforce utilization by implementing a customer relationship program involving routine personal communications and a web-based project management “Customer Center” - meeting time reduced by 75%. (McClellan)

Saved a minimum of 10% cost and 25% lead time reduction by streamlining the quality control function and applying Lean Manufacturing management methods. (Luxtec, Termiflex, Dataproducts)

Core Competencies

Quality Management Systems*FDA QSR*

Global Supply Chain*Supplier Quality Planning*

Proposals and quotations*Lean Manufacturing* Process Mapping*

Regulatory Affairs*Quality Engineering*Customer Service*

Process Validation*Risk Management*Design Verification*

Professional Experience

Boston Engineering Corporation April 2013 to present

Design and development consultancy: medical, industrial and consumer products– Sales $12M – 65 Employees

Quality Manager

Led a company-wide team in the development of a certifiable quality management system tailored to the business needs of a medical and commercial products design consultancy. Improved executive and quality oversight of projects by the establishment of a Project Review Board (PRB) resulting in timely identification of action items. Supported Sales via customer engagements, presentations and proposal review. Provided quality engineering services and regulatory guidance to projects.

Completed an aging ISO 9001/13485 certification initiative in first 6 months of employment

Established QMS training process and programs for all positions; won a $160K Mass Workforce Training Grant aimed at increasing critical skills across the organization.

On a medical device project led team effort on design control and risk management (ISO14971) compliance in support of IEC60601 3rd edition agency approval; selected and supported an electro-mechanical contract manufacturer through initial product runs for the main subassembly

Champion the value of quality processes at company meetings, during proposal development, on project teams, at PRB, management meetings, QMS Management Reviews and in one-on-ones at all levels of the organization

Johnson Precision November 2011 to March 2013

Tooling, qualification and fabrication of medical device parts and assemblies – Revenues $10M – 60 Employees

Director of Quality

Expanded and improved ISO 9001 quality systems to assure products meet established specifications and are in compliance with regulatory standards. Established and directed department quality programs and initiatives to drive continuous improvement.

Revitalized Quality Control program to provide proactive and effective support to high mix, short run injection molding production environment

Led successful company-wide QMS recertification program including adjustments necessary due to facility relocation and personnel reorganization; laid ground work for ISO 13485 certification in 2013

Reorganized department staff resulting in over 95% on-time delivery of metrology, process qualification, and new product introduction services

Radius Product Development October 2008 to August 2011

Design and implementation consultancy-consumer products & medical devices – Revenues $12M – 60 Employees

Director, Quality & Implementation

Provided leadership and direction to the ISO 9001/13485/FDA-QSR quality management system as variably applied to consumer and electronics, packaging, and medical device projects. Drove the adoption of best practices in quality engineering, design verification, and design transfer to production.

Completed a supply chain search and selection project involving $1M in tooling

Developed and staffed an enhanced design verification testing capability in support of key regulatory performance standards; completed project phases valued at $500K in revenue in FY2011

Expanded the approved supplier base by 30% with highly supportive partnerships

Earned an overall Customer Satisfaction rating of 3.5/5.0, exceeding expectations

HyperMed, Inc. 2007-2008

Design and manufacture of medical hyperspectral imaging systems-Revenue $500K start-up – 25 employees

Manager, Quality Assurance and Regulatory Affairs

Established a value-added QMS in compliance with the FDA and European requirements for this start-up company. System focus included the creation of hardware and software product specifications, verification and validation, configuration management, and field service. Maintained comprehensive and well-organized DHF, DMR, DHR, customer service, and complaint records. Staffed and managed the Documentation Control process.

Met QMS implementation deadline in conjunction with the first customer shipments

Achieved QMS acceptance via an FDA QSIT Level II baseline audit. There were no findings

Proactively led the quality engineering efforts on new and sustaining projects; assisted with an FDA 510(k) submission; provided quality policy and procedural training

McClellan Automation Systems 2004-2007

Design and build of custom assembly automation machinery-Revenue $3M – 20 employees

Operations Manager

Effectively managed multiple concurrent, complex orders. Coordinated project management, design engineering, procurement, assembly, debug and test, delivery, installation, and service of technically demanding custom automation machinery for medical device and commercial product assembly.

Developed tools for resource allocation, timely project cost tracking and projections, and management reporting. Provided aggressive operations support to the customer quotation process

Conducted comprehensive competitive analysis and market research that informed the annual strategic planning process

As customer liaison, provided effective account management resulting in adherence to planned schedule of receivables

Luxtec-PrimeSource Healthcare 1998-2002

Design and manufacture of medical devices for surgical illumination and visualization

-Revenue $15M – 75 employees

Quality Assurance and Regulatory Affairs Manager

Established a new QMS resulting in effective quality processes throughout the organization with particular emphasis on continual improvement of design and process controls.

Conceived and led company-wide project to design and implement a QMS in compliance with ISO, FDA and EU requirements; achieved certification on schedule and without difficulty

Increased outgoing quality level of outgoing by over 10% via more rigorous supplier corrective action and QC methods, and by initiating key assembly process improvement studies for light guide fabrication

Provided NPD quality engineering support to xenon light sources, headlight modules, light guides, and custom applications of endoscopic cameras. Drove concepts of design verification of thermal management solutions, advanced builds for new products, and standardized test protocols for production

Prior Experience

Cambridge Research and Instrumentation (now Caliper Life Sciences) – Quality Manager

Sanders Prototype Inc (now Solidscape)

WPI Termiflex – Quality Assurance Manager

Dataproducts (now Ricoh) – Quality Engineering Manager

Ferrofluidics (now Ferrotec) – Quality Control Manager

Teradyne

Bregani Consulting - Principal

Professional Affiliations & Associations

Certified Quality Engineer, American Society for Quality since 1986

ASQ Merrimack Valley section – currently Secretary

Technical Skills

Final assembly & test * ERP Systems * Microsoft Office Suite * Minitab * Project Management * Team Building * Supply Chain Management * Product Launch * Recruiting * Budgeting

Education & Professional Development

Masters of Business Administration Franklin Pierce College, Nashua, NH

Quality Assurance Studies, 16 credits UNH system

Graduate studies in geological sciences Harvard University, GSA&S

Bachelor of Science in Geology, Cum Laude Boston College, Chestnut Hill, MA

Contact this candidate