Quality

TATYANA ISHUTKINA

** ********* **.

Avon CT *****

Tel. 617-***-****

E-mail: **********@*****.***

SUMMARY OF QUALIFICATIONS

Ten-plus-year experience in quality system engineering for medical device industry and defense industry applications

Working knowledge of and experience with the following regulatory requirements: 21 CFR 820.30 (Design Controls) FDA's Quality System Regulation and ISO 13485 regulations.

Knowledge of manufacturing methods for medical implants and instruments (machining, welding, engraving, surface finishing, heat treatment, annealing, laser marking).

Transfer of design specifications into manufacturing specifications (Design Transfer) including document preparation for Design History Files/Device Master Records/Risk Management.

Development of Manufacturing Process Flow Charts

Advanced skills in performing specific analysis for connecting different players in the organization through problem structuring methodologies and matching developed concepts with company's development strategy and goals

PROFESSIONAL EXPERIENCE

Dec. 2011- present SCHWIPAR, Centre for Innovational Development, Avon, CT, Founder & Director

Work with systems integrators and/ or vendors

Identification of key factors (project components) to shape the future of product strategic development from its concept to full scale manufacture

Design detailed quality assessment of project components and formation of concept for inter-relationship between Company's sub-structure elements for development and tracking of investment capital budgets and product costs

Development of situational reports on different categories of company's employees such as engineers, management, workers, etc. for effective utilization of Company's resources

Development of concepts for understanding businesses enterprise uniqueness through quality concept architecture

Development of tools for collecting information of a high degree of importance to design a competitive advantage strategy

Feb. - present Panel O-50 Maritime Quality Culture, Society of Naval Architects and Marine Engineers (SNAME), Vice-Chair

Jan. 2001- Jul. 2011 Electric Boat Corporation, Groton, CT, Technical Product Quality Lead

Responsible for management activities of Technical Product Quality (TPQ) program in a functional area of 650+ designers and engineers

Responsible for development and recommendation of procedures to monitor TPQ program in each specific group (by product) in seven electrical departments

Lead annual preparation /participation in the ISO quality system certification at the Company level

Chair and report out of all quality meetings to include department quality meetings, discipline quality meetings, company-wide quality meetings, quality meetings with the Customer and other team meetings

Initiate / facilitate Lean/ Six Sigma projects in cross-functional environment with Customer's involvement

Coordinate the development of technical product documentation required for project execution such as Design Failure Mode and Effects Analysis (DFMEA) and Design for Manufacturability (DFM)

Improved productivity by assessing functional area quality performance through customer feedback by seventeen percent

Developed vendor selection matrix procedure

Created network learning and knowledge-sharing to optimize enterprise value streams

Responsible for financial portfolio and administrative operation of joint projects with universities in the Electrical discipline

Oct. 1997- Jan. 2001 Honeywell Sensing and Control, Acton, MA, Development Engineer

Provided technical assistance to carry out problem analysis and investigations related to equipment and process operation

Modeling, fabrication, testing and evaluation of pressure transducers for medical and industrial applications

Research and characterization of inactive materials, including glass paste, epoxies, glob-top encapsulants, and electroactive materials including silicon, germanium, and silicon on insulator

Support continuous improvement activities for product quality and reliability using Six Sigma tools

Coordinate the development of technical product documentation required for project execution such as technical specifications, test plans, DFMEA, DFM / DFA, etc.

Establish, track and report of project plans through use of established Project Management Tools and use of best project management practices (schedules / resource plan / project tracking)

Isolation and verification of the critical processes and redesign them in order to reduce the amount of non-value-adding work

Ensure the timely preparation and execution of engineering project documentation (ECN’s, BOM’s, Drawings, and Specifications)

Knowledge of materials employed in medical implants and instruments (SST 17-4, series 300 & 400 SST, titanium, UHMWPE).

Interface and coordinate follow ups with Marketing, Manufacturing, Quality, Purchasing, and Outside Suppliers to ensure timely delivery of all project requirements / deliverables.

Oct. 1996- Jul. 1997 NEC America, Hillsboro, OR, Engineer

Responsible for the analysis, measurement and improvement of a PCB assembly, including SMT, BGA, and THT

Developed project schedules to Production Part Approval Process (PPAP) guidelines in support of project goals and objectives

Responsible for cost estimating, proposal preparation and reporting on soldering criteria for multiple programs

Developed and implemented standards resulting in a $218,000 annual savings

Assisted in investigating and initiating correction action on manufacturing problems associated with the inspection of company produced products

Reported directly to Associate Chief Engineer of the NEC Oregon Plant

EDUCATION

2005 Green Belt Certification (Minitab 15 based); Breakthrough Management Group (BMG)

2004 Process Model Training (Version 5.3.0)

2002 Lean Enterprise Certification; Knolls Atomic Power Laboratory (KAPL)

2002 Master of Science in Administrative Studies, Boston College, Chestnut Hill, MA

1981 Master of Science in Electrical Engineering, N. Novgorod State Technical University,

Nizhny Novgorod, Russia

Membership Society of Women Engineers, since 1998

Society of Naval Architects and Marine Engineers

National Defense Industrial Association

US citizen

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