MARK BOUFFARD

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

Phone: 508-***-****

Shrewsbury, MA 01545

ab6h03@r.postjobfree.com

PROFILE OF QUALIFICATIONS

Demonstrates strong management leadership to direct resources and provide

clear objectives. I have a passion for people and their professional

development. Realize that a heavy investment in people by evaluating

performance, coaching, and building self-confidence is the key to creating

a high performing team and value within an organization.

Experience with the following manufacturing disciplines; Six Sigma, JIT,

Kaizens, 5S, Lean Manufacturing and cGMP. Instituted several proven

continuous improvement teams focusing on key performance indicators.

Lonza Biologics, Hopkinton, MA

Central Services Manufacturing Manager (June 2012 to Present)

. Managed a team of Central Service professionals responsible for buffer

and media preparation for the fermentation and purification process.

Equipment consisted of mixing tanks, autoclave, depyrogenation, pH

conductivity meters, CIP skids, filter integrity testers, and glass wash.

. Familiar with bioreactors, centrifuges, filtration, and chromatography

columns.

. Proficient in the use of TrackWise, LIMS, Knowledge Wire and SAP tracking

software.

. Writing of problem records, deviations, change orders and editing or

creating standard operating procedures.

. Ensured compliance with FDA, state, and federal regulations. Ensured cGMP

compliance and adherence on all solution preparation documentation.

. Resource planning in accordance with the scheduling requirements of the

areas priorities.

Tegra Medical Devices, Franklin, MA

Business Unit Manager (June 2010 to March 2012)

. Managed under the quality management systems to conform under the

guidelines of the ISO-13485 FDA quality regulations.

. Responsible for overseeing a high volume, contract manufacturing surgical

instrumentation medical device business unit. Consisting of sixty-five

direct reports and over 3000 products.

. Associated equipment consisted of laser cutting, laser welding, laser

engraving, CNC Swiss screw machines, center less grinders, EDM wire, CNC

millers, and angle grinders.

. Led a team of individuals that instituted 5S Lean Manufacturing

implementation. The team instituted changes to equipment setups through

SMED events and reduced times by 60%. Team also reduced WIP by 50%.

. Equipment and process full characterization understanding, utilizing

design failure mode and effects analysis (DFMEA), process failure mode

and effects analysis (PFMEA) installation qualification (IQ), operation

qualification (OQ), and process qualifications (PQ) to have a complete

understanding of process capability.

. Worked with CAPA, NCR, ECN, MDHR, DHR, MRB, and FDA audits.

. Work closely with managing supply chain to ensure pricing, lead times,

with the goal to have proper levels of work in process (WIP) while trying

to maintain a just in time (JIT) discipline to ensure quick inventory

turns and reduce inventory liability.

Bruce Diamond Corporation, Attleboro, MA

Production / Quality Manager (October 2008 to June 2010)

. Instituted a quality system consisting of corrective action plan, non-

conforming material review, employee training system, document control

traceability, calibration process, engineering change orders, and

creation of operation work instruction for all MFG processes.

. Through lean manufacturing initiatives I created a stockroom area

complete with part numbers and product accounts within the companies

QuickBooks inventory management software. During this process I reduced

our inventory levels by 35% through excessive and obsolescence material.

. Responsible for 35 direct reports associated with material control,

engineering, quality, and manufacturing.

. Created continuous improvement teams to focus on streamlining

manufacturing processes to reduce cycle times increase product yields and

reduce product cost. These teams had positive results by reducing setup

times, designing a completely new MFG floor layout and instituting a just

in time environment.

. Through better planning, scheduling and organization of the MFG resources

I was able to increase our on time deliveries from 80 to 98%.

GSI Group Laser systems division, Bedford and Wilmington, MA

Manufacturing Manager (2006 to September 10, 2008)

. As a manufacturing manager for GSI laser systems division I had

responsibility of twenty direct reports. My team was responsible for pre-

integration, integration and testing of capital laser equipment used in

the semiconductor industry.

. I was responsible for material and resource planning, scheduling, and on

time deliverables. Reduced cycle time by 50% and improved on time

delivery for the WaferMark division from 80% to 100%. I reduced average

overtime cost per system from $5000.00 to $230.00 per system shipped.

. Through lean manufacturing I was able to streamline the assembly process

by identifying key areas of opportunities. We were able to increase our

efficiencies with a complete floor layout of the manufacturing process.

Other improvements that led to the improved efficiencies were material

alignment, creating a training certification process for all

manufacturing technicians and reducing assembly steps.

. Key metrics were yield, cycle times, labor cost, budgeting targets,

defects per unit shipped, on time delivery and customer satisfaction.

. Through the teams efforts we were able to improve delivery times with our

supply chain to help improve on time delivery and material management.

Advanced Micro sensors, Shrewsbury, MA

Senior Product Specialist (1999 to June 26, 2006)

. Responsible for designing and developing processes to manufacture thin

film recording heads for the storage industry along with micro electrical

mechanical systems used in multiple applications. Area of processing

consisted of photolithography, vacuum deposited sputtered films, wet and

dry etching, and die slicing.

. Team leader assigned to convert a three inch wafer fab into a six inch

class 100 wafer fab. This change would decrease cycle times by 25%,

reduce consumable cost 30%, and reduction in manpower by 15%. This

conversion cost a little over 2.5 million dollars with at budget of 3.2

million.

. Working with the quality team we aligned the company's quality systems

and documentation to qualify for ISO-9001-2000, we were certified by the

National Quality Association in 2004. I continued my involvement by

conducting internal audits and issuing reports on my finding of non-

conformances and observation.

Digital Equipment / Quantum Corporation

Senior Product Specialist and Asia Operations Manager (1986 to 1999)

. In a class 100 clean room I worked on several deposition and ion etching

systems consisting of e-beam CHA, IBD Commonwealth, IBE Veeco, PVD CVC,

IBE Ion Tech, PVD Alcatel and Leybold.

. Material consisted of Al203, Ru, Au, Cu, Rh, CoPt, Cr, Ti Ta, NiFe, AlN,

CZT, and TiW.

. Led global teams to develop and setup businesses and technical processes

transfer for two Asia-Pacific manufacturing centers.

. Working with a capital budget of 25M, I managed the purchasing of

equipment and supplies to setup a high volume manufacturing centers in

Panyu China and Batam Indonesia. Working closely with equipment suppliers

tracking deliverables to meet the timeline of the business. Within eight

weeks of training the China facility was operational. Within an eighteen-

month period they were producing 700,000 recordings heads a week with

yield starting at 40% and improving to 70%.

EDUCATION

Business Program, Quincy College, Quincy, MA

Life experience: Bachelors degree equivalent experience with proven

leadership and responsibilities with over twenty years working for

reputable companies in key positions within each organization.

Military 2004 to Present, United States Coast Guard Auxiliary Division 5

1NR district Boston.

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