Quality Assurance Engineering

MARIO DELSIGNORE

** ***** ********* ( New Hyde Park, New York 11040 ( H: 516-***-****

C: 732-***-****

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

DIRECTOR of QUALITY ASSURANCE and ENGINEERING

Six Sigma ( New Product Development ( Continuous Improvement ( Quality

Assurance ( Quality Engineering ( Statistical Analysis ( FDA (

R&D/Manufacturing Integration ( Training ( Validations ( Design of

Experiments ( FMECA ( Auditing (

Engineering professional with a successful career in analytical, technical

and engineering expertise combined with achievement in cost reduction,

quality improvement, project and engineering team management. Effective

vendor, customer, and inter-departmental and facility liaison with

outstanding troubleshooting, problem-solving, and relationship management

skills. Strong knowledge with regulatory compliance under FDA 21 CFR Part

820, OSHA, GMPs, and ISO 13485.

PROFESSIONAL EXPERIENCE

INTERNATIONAL TECHNIDYNE CORPORATION (ITC) ( Piscataway, NJ

01/07 to Present

(80MM dollar IVDD systems manufacturer)

Director of Quality Assurance & Quality Engineering - ITC - June 2012 to

Present

The Director of Quality Assurance & Engineering maintains overall

responsibility for the Quality Assurance & Engineering functions which

focus on customer satisfaction, product quality and process reliability,

design validation and transfer, process and change validation, complaint

and non-conforming product investigation and corrective and preventive

action.

. I am accountable for the strategic planning and oversight of all

department activities, the planning and implementation of budgets, and

for working closely with functional managers by providing regular

guidance and general direction to ensure goals are met or exceeded.

. My position regularly deals with difficult, serious and abstract

issues within the department and cross-functionally, and is

responsible for making key decisions that will impact both operational

and organizational success.

. I also function as a member of the Company's Senior Leadership Team

playing a vital role in the development of Company objectives and the

achievement of business goals.

. Well respected throughout the organization as a team player who is

willing ensure product meets the highest quality standards

. Reduced non-conformance turnaround time from ninety (90) to thirty

(30) days

. Improved process yields through engineering studies and validations on

key product lines from 85% to 95%

. Received excellent remarks from ISO governing body (TUV) on the

process validation system for 3 consecutive years

. Member of the following Boards: CAPA Steering Committee; Validation

Review Board (chairman), Materials Review Board, Change Control Board

. Established the Manufacturing Operations/Quality partnership to ensure

timely resolution of day-to-day activities

CURRENT DUTIES/RESPONSIBILITIES:

. Assure quality products and processes; establish quality and reliability

standards by working cross-functionally and with Senior Leadership to

study product and consumer requirements

. Establish raw material standards by studying manufacturing and

engineering requirements; confer and negotiate with suppliers; devising

testing methods and procedures

. Establish in-process product inspection standards by studying

manufacturing methods and devising test methods and procedures

. Establish product quality documentation system by writing and updating

quality assurance procedures

. Maintain product quality by ensuring compliance with quality assurance

policies and procedures related to relevant regulations

. Collaborate with Senior Leadership to develop new product and engineering

designs as well as manufacturing and training methods

. Prepare product and process quality reports by collecting, analyzing, and

summarizing data and trends

. Complete quality assurance operational requirements

. Maintain professional and technical knowledge, networks and memberships

. Achieve financial objectives by preparing quality assurance budgets,

scheduling expenditures, analyzing variances and initiating corrective

actions

. Work cross-functionally to establish strategies, priorities and goals for

risk management, failure analysis, process validation, process

reliability, trend analysis, statistical quality and process control

. Develop, execute and maintain short and long term strategic plans;

develop and implement related policies and procedures; communicate and

guide functional managers accordingly

. Support company wide initiatives

. Ensure cost effective measures and budget compliance; develop cost saving

initiatives to meet or exceed financial performance requirements

. Provide technical, logistical and planning expertise to resolve

manufacturing issues

. Develop and implement plans for continuous improvement

. Actively participate as a member of the Company's Senior Leadership Team

. Identify and correct abstract and difficult department issues

. Mentor functional managers

. Lead and motivate staff; promote employee involvement, operational

excellence, internal career development, and foster positive

organizational culture

Director of Quality Engineering - ITC- Jan. 2007 to June 2012

. Led deployment of Quality Engineering teams and Continual Improvement

initiatives.

. Strongly focused on customer satisfaction, product quality and product

and process reliability. This included quality management tools such as

risk management (FMECA), voice of customer and quality function

deployment into the quality system for design validation, design

transfer, process validation, change validation, complaint investigation,

non-conforming product investigation and CAPA.

. Lead Quality Improvement Projects directed at key process areas within

the organization that lead to breakthrough quality and cost saving

improvements.

. Responsible for assuring each project team applied appropriate

statistical tools and techniques, following the DMAIC principle. Trained

as a six sigma black belt by the American Society of Quality (January

2003)

. Was a member of the ITC FDA Steering Committee from Jan. 2009 to Mar.

2010 to resolve and rectify thirty-two (32) audit observations.

TECHNICAL KNOWLEDGE, SKILLS AND ABILITIES:

. Past experience and working knowledge of Quality Engineering principles

such as Risk Management, Failure Analysis, Process Validation, Process

Reliability, Trend Analysis, Statistical Quality Control, Statistical

Process Control, Descriptive Statistics

. Certified Six Sigma Black Belt preferred, with knowledge of the DMAIC and

DFSS methodologies.

. Knowledge of VOC, QFD techniques

. Past experience and working knowledge of project management techniques,

and demonstrated ability to manage interdisciplinary project teams

efficiently

. Knowledge of system and process management methodologies

. Ability to develop and deploy DOE tools/techniques

. Familiarity with quality analysis tools/techniques such as Pareto chart,

run charts, scatters diagrams, regression analysis, SIPOC Diagrams

. Familiar with quality improvement team facilitation tools/techniques such

as agenda planning, group facilitation and decision-making,

brainstorming, group effeminizing, and prioritizing. Effective listening

and conflict resolution

. Proven coaching skills including team player development, project

management skills, and ability to communicate effectively with all levels

. Effective decision making and analytical, ability to render sound

decisions and recommendations after receiving related data,

circumstances, options and consequences

. Financial skills to understand and use business financial data

. Strong problem solving skills

. Effective time management and multi-tasking skills

. Strong communication skills (verbal, written, listening, presentation)

. Strong PC skills, including experience with Minitab and Microsoft

Project.

PALL CORPORATION ( East Hills, NY Oct. 1987 to Jan. 2007

(Five Billion Dollar, Filtration Products & Separation Systems

Manufacturer)

Senior Manager of Quality Engineering - Pall Life Sciences ( 5/2000 to

01/2007

. Implemented use of engineering studies and IQ/OQ/PQ validation

protocols stressing the use of statistical methods (i.e. ANOVA,

Process Capability, Gage R&R, DoE's) to verify product meets its pre-

determined specifications.

. Created engineering study template for existing product/process

transfers. The study is used to supplement OQ and uses statistical

methods to determine process robustness.

. Developed "Six Sigma Road Map" corporate policy for the use and

implementation of the Six Sigma tools and methodology.

. Performed numerous training sessions for senior management, technical

and manufacturing personnel at all manufacturing facilities on the

following:

~ Six Sigma Road Map

~ Design of Experiments (DoE's)

~ Failure Mode and Effect Analysis (FMECA)

~ Implementation of Six Sigma Tools

~ Validation Methods

. Trained as Six Sigma Black Belt by American Society of Quality

(October 2002-January 2003)

. Drove cultural change staging/setting up Six Sigma Champion Training

Sessions for over 100 senior management personnel.

~ Training was held at off-site facilities in Ann Arbor,

Michigan, Pomona, California, Long Island, New York, and

Portsmouth, England.

~ Requested by ASQ instructor to participate and assist with

training sessions in New York and England.

. Selected as a member of Task Force by Vice President of R&D and

Product Engineering as part of a cross-functional team to participate

in reconciling product quality issues; implemented numerous corrective

actions, performed multiple engineering studies and validations to

increase product quality and manufacturing efficiencies (March 2004-

December 2004).

Engineering Manager - Pall East Hills Manufacturing ( Mar.1999 to May 2000

Managed daily engineering production, equipment, and media group

maintenance operations for this Fortune 1000 company. Provided

engineering support and investigations in conjunction with Quality

Assurance Department and R&D for product occurrences. Performed

engineering analysis, root cause investigations, and proposed

corrective actions for products manufactured outside the scope of

engineering and product specifications. Coordinated product and/or

process transfers from R&D into manufacturing through validation

methods. Oversaw all phases of documentation process such as quality

control procedures and maintenance guidelines. Supervised, trained,

and reviewed team of eight engineers.

~ Member of Pall East Hills Manufacturing Operations Committee

that oversaw continuous product/process improvements as well as

initiated cost reduction projects.

~ Internal Audit Team Engineering Representative which helped

manage, perform and verify work affecting the quality of all

products manufactured at Pall East Hills.

Project Manager - Biomedical Manufacturing Engineering ( Sept. 1996 to Mar.

1999

Oversaw transfer of processes from R&D into manufacturing to comply

with FDA regulatory guidelines. Provided technical training of

manufacturing personnel and the transfer of products, processes and

technology. Direct manufacturing liaison among Japanese sales,

marketing and manufacturing facilities. Improved product performance

and process efficiency.

~ Transferred 110 products from Biomedical Division within one

year given time-line, permitted company to utilize fiscal tax

benefits in Puerto Rico, Ireland, and England.

~ Provided superior quality product to Asian markets, therefore,

eliminating costly inspections in both Puerto Rico and Japan.

Technology Transfer Manager ( Aug. 1994 to Sept. 1996

Provided technical support to maintain and improve technologies.

Purchased, validated, and transferred equipment to Puerto Rico,

England, and Ireland facilities. Trained personnel from these

facilities in processes and equipment for transfer of products.

~ Transferred $80MM in product and equipment to Puerto Rico and

England.

~ Two-time recipient of Recognition Award from Pall Biomedical,

Inc. for outstanding technical support, 1994 and 1995.

Project Engineer ( Oct. 1987 to Aug. 1994

~ Coordinated equipment installations among manufacturing, R&D,

and maintenance departments.

~ Transferred products, processes, and equipment from R&D into

manufacturing. Directed and trained maintenance and

manufacturing workforce in prescribed procedures.

KENTILE FLOORS, INC. ( Brooklyn, NY May 1981

to Oct. 1987

($500MM, Floor Tile Manufacturer)

Project Engineer

Held full autonomy for coordinating with vendors for the purchase of

equipment. Obtained contract bids for equipment/machinery

installation in Brooklyn, Chicago, and New Jersey plants; supervised

installations. Authorized and approved mechanical drawings for

fabrication and field installation. Troubleshot problems on

production line equipment, coordinated equipment installations among

manufacturing, R&D and maintenance departments. Transferred products,

processes, and equipment from R&D into manufacturing. Directed and

trained maintenance and manufacturing workforce.

EDUCATION

Manhattan College, Riverdale, NY

Mechanical Engineering

References available upon request.

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