Engineer Quality

DANIELA PETROVA-TCHONEVA

Orlando, FL *****, Cell: 402-***-****

e-mail: acy6gw@r.postjobfree.com

US Citizen

SUMMARY

ASQ certified quality professional with experience in medical and military device industries, able to improve your quality system by scientific methods of process control, metrology, project leadership and new product development

AREAS OF EXPERTISE

Application of international and national standards, concerning Quality Management

Systems for manufacturing, testing and calibration (ISO 9000; ISO13485, ISO17025, AS9100)

Quality control, statistical process control, testing and measurement of materials,

components, coatings and devices, including environmental and reliability tests

Calibration of measuring devices, gages, standard reference materials

Technologies for obtainment and processing of glasses, ceramics and crystals

Optical methods for study of materials and components

PROFESSIONAL EXPERIENCE

Quality Assurance Experience:

1.Building up Quality systems in compliance with ISO9000, ISO13845, ISO17025, AS9100, 21CFR 820. Writing Standard Operation Procedures, Work Instructions, Test methods

2.Auditing-internal and second party

3.Metrology:

- Inspection, test and measuring equipment calibration and maintenance.

- Out of tolerance and nonconforming conditions investigations. CAPAs. Trend analysis

- TAR (test accuracy ratios) and uncertainty analysis; Gage R&R studies

- Testing new equipment for qualification; validation of testing process

4. Statistical process control: Metrics; tolerances; control charts; Data analysis; Capability

Studies; Testing for comparison of means and standard deviations; hypothesis testing

5.Validation of processes (for example: grinding, polishing, annealing, etc.)

6.Product surveillance-complaints investigation: device history records; technical evaluations and investigations; post marketing reviews

7.Continuous improvement projects(DMAIC approach)

Science and Engineering Experience:

1.High temperature technologies for obtaining and processing of ceramics, glass and crystals: High dense alumina and zirconia for medical implants; Transparent ceramics for lasers; translucent ceramics for orthodontics: Single crystals for lasers

2.Optical and laser methods for testing of devices, components and materials

ACCOMPLISHMENTS DURING EMPLOYMENT

November 2014 – December 2015 (1 year contract)

Zimmer Biomet Inc., Warsaw, IN, USA, (Medical device, orthopedic implants)

Sr. Quality Engineer, contract position

Team member of CAPA (Corrective and Preventive Action) Remediation and Acceleration project

Post market surveillance. Handling of complaints – Device History Records review, Technical evaluations and investigations; marketing reports; FDA recalls

January 2013 – June 2014

Dentsply International Inc, Sarasota FL, USA, (Medical device, orthodontic brackets)

Ceramic Engineer

* Engineering leadership in development of translucent Al2O3 ceramics for orthodontic brackets

- Material Specification development; statistical processing of the data; built in product quality

- research for new materials applicable in orthodontics; evaluation of vendor’s production

- prepared plans, programs, presentations, reported to the top management

July 2010 – July 2012

VLOC, II-VI Inc, New Port Richey, FL (Optical components for medical and military applications)

Sr. Project Engineer with QA and Metrology functions

Engineering leadership for government project “Polycrystalline laser gain material” (transparent

ceramics), US Air Force program “Title III”

- organized, optimized and execute the samples processing and testing; developed tools

- developed new methods for testing, analyzed the test results, gave feed back to the technology

- Full testing for Qualification of new equipment: functional tests, gage R&R, capability, stability,

statistical testing and data processing using MiniTab software, wrote work instructions, reported

The results exceeded the Phase 1 project requirements.

November 2009 – April 2010 (6 m contract)

UCF, CREOL, Orlando, FL

Research scientist

Developed technologies for obtainment and optical testing of photo-thermo-refractive glasses,

used for diffraction gratings.(DARPA Project)

November 2008 – April 2009 (6 m contract)

Bionetics Co. ( NASA Standards Calibration Laboratory), Kennedy Space Center, FL, USA

Metrologist

Performed calibrations and Uncertainty analysis in Mass and Dimensional Standards Labs Trained on measurements risk analysis

January 2006 – March 2008

ALCON Refractive Horizons Inc. Orlando, FL, USA (Laser medical device for eye surgery) Quality Engineer –

Led the Metrology/Calibration program for manufacturing of laser equipment for eye surgery - Determination of suitability for use of the inspection, measuring and test equipment

- Calibration, preventive maintenance, repair and tracking of about 2000 active measuring devices; Investigation of “Out of tolerance” and “Non-conforming” conditions; trend analysis; root cause analysis; Corrective and Preventive Actions assignments

- Participated in internal and external audits; continuously improvement projects, equipment comparisons and validations using statistical methods; reported to the top management

For the time of employment the metrology program functioned perfectly, Registrar and FDA audits

passed with no remarks, technical service was supplied with calibrated tools timely.

ACADEMIC EDUCATION

Ph.D. in Physics, University of Sofia, Bulgaria, Moscow Energy Institute, Russia

Research on new laser crystals

Engineer-Chemist, Higher Institute of Chemical Technology, Sofia, Bulgaria

Area of concentration: Technology of Glass and Ceramics

CERTIFICATIONS, SPECIALIZATIONS AND TRAINING

ASQ Certified Six Sigma Green Belt, Through exam, USA, 2008

ASQ Certified Quality Engineer, Through exam, USA, 2004; renewed in 2007

A2LA, Laboratory Assessor (ISO 17025), Training and exam, Columbia, MD, USA, 2004

ASQ Certified Calibration Technician, Through exam, USA, 2007

ASQ Certified Quality Technician, Through exam, USA, 2004

Calibration Manager4.x software, Blue Mountain Quality Resources, 2006

Excel XP and Power Point XP, New Horizons Learning Center, 2006

NIST, Optoelectronics Division, Boulder, CO, USA, Laser Measurements short course

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