Quality Control Medical Device

Evelyn S. Otero Concepcion

Mobile: 787-***-****

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

Urb. Quinta del Rio, camino de chalet d7

Bayamon PR, 00961

OVERVIEW:

Over (2) years of Laboratory Research experience. Apply knowledge in

laboratory standard mehods and testing. Strong knowledge of laboratory

instruments such as: Incubators, Microscopes, Balances, Chart recorders,

autoclave, colony counter, laminar flow bench, Particle counter, Microbial

counter, Cabins for gas extraction, Cabins for PCR, Chromatography,

Pipettes, readers, refrigerators, and Centrifugal. Knowledge on a variety

of applications programs and software such as: Word Processing, Retail Pro,

Power Point, Excel, MicroScan, Lab Pro and Documentum. Understand and

comply with laboratory operational procedures, related policies and

industry.

SKILLS:

. Proven strong management, leadership and coaching skills which

expedite successful coordination and achievement of goals through

teamwork.

. Excellent working with team and promoting the good work environment.

. Ability to plan, organize and prioritize work.

. Compeitive analitical skills.

. Comprehend the importance of making the customer's needs,

circumstances and expectations as a primary focus.

WORK EXPERIENCE:

Stryker (April 2012-May 2013)

. Quality Inspector

. Ensure Regulatory compliance in area to cGMP's of all medical device

regulatory agencies (FDA and TUV).

. Work with QE's and product teams to identify areas for risk reduction

and error proofing processes and work on implementation of these.

. Perform internal quality audits.

. Trending and analysis of key Quality metrics.

. Responsible for the timely analysis of customer complaints to

acceptable Quality Standard supporting Divisional and Operational

goals and objectives.

RESEARCH EXPERIENCE:

Laboratory of Dr. Carlos Santos (August 2011 -May 2012)

. Studying communities of aquatic insects of different Forest of PR.

. In samples of Corbicula fluminea, took measures, was collected by size

according to the location of the bodies through a light microscope.

. In samples from rivers and lakes of PR was identified and classified.

different species of organisms as different types of snails.

. Perform setup clean up and operation analytical equipment.

. Use of Microbial identification tests: Staining, RYU (KOH 3%), Slide

and Plate Culture, Grow promotion, Oxidase and Viability.

. Prepare and dispose of both biohazard and non-biohazard solutions for

use in product.

Hospital Auxilio Mutuo (January 2011-August 2011)

. Pediatric Volunteer

. I offered aid to the companion of the patient.

. Explained and offered the services offered by the office of Hospital

Volunteers.

. Leader of the group of voluntary students of the Hospital.

. Knowledge's and techniques on the Medical Industry.

Doping Center, Central American Games at Mayaguez PR (January 2010-July

2010)

. Report and escort the person to the doping station.

. Team leader at Doping Station.

. In the Samples it takes measures from the pH and the densities in the

urine.

. In charge of collecting urine samples.

. Execute quality control tasks.

Laboratory of Dr. Jaime Acosta (August 2008-2009)

. Classifying different types of arthropods in Puerto Rico.

. Collect and analyze samples of ants using light microscopy.

. Review and improve procedures.

. Provide job training and support in different areas.

EDUCATION:

. Polytechnic University of Puerto Rico

Master in Environmental Management - 2012-2014

. University of Puerto Rico, Mayag ez Campus

Bachelor in Biology - 2006-2011

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