Sign in

Quality Assurance Management

Elmira, NY, 14905
85K - 95K
August 10, 2012

Contact this candidate


MARK TRIFOSO *** West Clinton Street

Elmira, NY *4905


OBJECTIVE: Quality, Engineering, or Operations Management


High-energy manager with experience in the medical device and consumer electronics manufacturing facilities. Eighteen years in a highly automated 24 hour per day manufacturing facility producing 1.2 million units per year. Proven ability in managing separate functional areas simultaneously. Significant accomplishments in quality assurance, environmental management and manufacturing engineering. Dedicated to improving product quality through innovative programs while achieving significant savings. Solid application of lean manufacturing techniques. Project champion for Six Sigma. Excel at budget management and enforcement of austerity budgets. Extensive national and international travel experience.


SYNTHES (USA) Horseheads, NY 2004 - 2012

Synthes is a leading international medical device company, specializing in the development, manufacturing, and marketing of instruments, implants and biomaterials for surgical fixations, corrections and regeneration of the human skeleton and soft tissues. Member of the startup team for Synthes as a quality engineer for a new manufacturing facility in the Horseheads, NY area. Promoted rapidly and have extensive quality experience in FDA regulated environment.

Quality Assurance Supervisor 2010 - 2012

• Responsible for a team of six metrology technicians and three document control specialists.

• Well-versed in the ISO 13485:2003 quality management system for medical device implants. Part 820 – CFR Code of Federal Regulations Title 21

• Accountable for $1.25 million in of cost reduction initiatives in the Cal Lab.

Quality Engineering Supervisor 2007 – 2010

• Responsible for a team of ten engineers and one technician in support of new product launches and sustaining established product lines.

• Approved engineering instructions, standard operating procedures, purchasing specifications and capital appropriations.

• Successfully implemented 25 new product launches with limited QE resources.


Quality Engineer 2004 - 2007

• Provided quality engineering support to Quality, Manufacturing, Product Development and Suppliers.

• Participated in new product development programs, design reviews and approve design for quality reliability requirements.

• Lead failures investigations and problems analysis regarding customer complaints, nonconforming materials and vendor quality problems to improve quality, reliability and cost.

• Served as chairperson for the Material Review Board.

• Approve product and process changes.

• Establish statistical based inspection procedures for purchased and manufactured components.

• Design gauging and develop tools and techniques to measure pertinent product parameters to assure product complies with engineering drawings.

• Assist in performing process validation / capability.


Member of the initial start up team for as a quality engineer. Trained in Fukaya, Japan with a core group of management and technical experts designated to be the core start up staff for the plant opening in 1986. Promoted to QA Supervisor in 1987 and progressed rapidly to Senior Management.

Senior Manager of Quality Assurance 1997 – 2003

Member of the Management Committee directly reporting to the President. Successfully integrated and managed both the Quality Management and the Environmental Management Systems for a seven-year period with direct responsibility for monitoring and evaluating CRT product quality. Ensured that that an effective Quality Management System was established, implemented, and maintained to achieve customer satisfaction. The quality organization consisted of 36 direct and non direct reports with a 2.1 million annual budget.

• Directed all activities relative to achieving the ISO14001, 1994-E certification in 1998.

• Maintained the ISO 9001,1994 Quality Management System (QMS) certification since 1997 and directed the 9001:2000 re-certification.

• Performed the annual EMS and QMS management review to ensure the systems continuing suitability and effectiveness in satisfying ISO requirements.

• Successfully completed a Six Sigma project to reduce internal lot failure from 18% to 3% blocked apertures and screen defects in conjunction with 273k reduction in of inspection costs.

• Improved customer satisfaction and product quality by developing the concept of Customer Quality Teams. A three member team from quality, process engineering and manufacturing was assigned to service each customer. Responded within 24 hours to customer issues and achieved an overall quality level of 3500PPM.


Senior Manager of Manufacturing Engineering 1993 – 1997

Directly responsible for preparing the factory readiness for the vertical start up of new product tube types and for the creation, maintenance and distribution of Engineering Instructions which defined process methods and parameters, product characteristics and control procedures. Identified, recorded and provided solutions to major process and product problems. Manage 36 professional, and technical and clerical employees.

• Responsible for the successful CRT design validation of 8 new CRT tube types from 1993 -1997.

• Introduced approximately 60 design changes on CRT tube types resulting in cost down or value added improvements, which reduced the product manufacturing cost.

• Designed and facilitated the master three week technical training program for 25 Uptron Color Picture Limited trainees from India.

• Successfully managed the overall department administration, planning and control.


Elmira College, Elmira, NY

Working towards a B.S. degree in Computer Systems and Programming

Rochester Institute of Technology

B.T. in Electrical Engineering

Corning Community College

A.S. Electrical Engineering Technology


• RAB-Approved ISO 9001:2000 Transition Training for RAB-Certified auditors

• Toshiba America Group Executive Management Seminar

• ANSI-RAB Accredited ISO-14001 Environmental Management Lead Auditor

• Statistical Engineering Problem Solving, Toshiba

• Green Belt training for Six Sigma

• Toshiba Overseas Management Course

• Cornell University School of Industrial and Labor Relations: Principal negotiations; The Practice of Supervision.


• Chemung County YMCA, Board of Directors

• Member of Mark Twain Golf Course Dewbirds PGA Association


Contact this candidate