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Medical Device Quality

Location:
Cary, North Carolina, United States
Posted:
January 29, 2018

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GABRIELA GONZALEZ

**** **** **. ***********, ** *7560 Cell: 919-***-**** E-mail: ac38xd@r.postjobfree.com Professional Summary

Experienced and resourceful bilingual (English/Spanish) Pharmaceutical Chemist offering outstanding skills for quality control of manufacturing medical devices and production industries. Organized and goal-oriented professional, committed to contributing to organizational objectives as a member of a committed team. Works well independently as well as collaboratively. Possesses outstanding organizational skills with focus on quality and detail. Summary of Qualifications

• Medical Device Compliance

• Results Oriented

• Problem Resolution

• Failure Modes & Effects Analysis

• Strategic Planning

• Experience in medical device design, production, test and inspection

• Deep knowledge of FDA Medical Device Reporting and international medical device regulations

• Good understanding of ISO 9001:2008, FDA 21CFR820, ISO 13485, QFD, SPC, AQP, FMEA and Control Plan Work History

Quality Assurance Medical Device – Nypro a Jabil Company – Tijuana, Mexico 12/2015 to 12/2016 Quality Engineer for “Class II” Advanced Wound Management for the customer Smith & Nephew, with the line of production of VersajetTM II Exact and Plus Hydrosurgery System has uses a pressurized stream of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications, and suction device RenasysTM vacuum-assisted pressure below the wound surface to help promote healing.

• Analyzed process and products and implemented enhanced quality systems to processes such as six sigma and 5S.

• Coordinated with operations department and ensure that new products were produced in accordance to procedures.

• Set and monitored product standards, examining samples of raw products and processing test, to ensure the quality of all finished products.

• Managed and supporting the Quality Department to planning, Check, Performance and Follow up of resources and activities of the area.

• Updated and generate the documentation for existing and new processes.

• Ensured that all corrective and preventive actions were taken in required timeline.

• Trained Manufacturing technicians with the new assemble processes and Corrective Actions.

• Performed support to Customer complains and follows up of Corrective and Preventive Actions.

• Coordinate with Regulatory Affairs and ensured that all the documentation were maintained in accordance to FDA regulation.

Junior Research Scientist – Unit of Biophysics and Bioengineering, University of Barcelona – Barcelona, Spain 09/2013 to 07/2015

Designed and developed a microfluidic device of Polydimethylsiloxane (PDMS) with the characteristic of limiting the area of cellular growth, specifically in the surface area where is desired the gaseous exchange, imitating the frequency of the Oxygen desaturations occurred in patients with severe Sleep Apnea.

• Innovated a microfluidic device to be used as a cyclic system to imitate sleep apneas.

• Studied the influenced of macrophages submitted to normoxia (control group), intermittent hypoxia, chronic hypoxia, in order to study their expressions.

• Investigated if the different conditions of hypoxia, stimulates the change of phenotype, such as, the segregation of Prostaglandin E2 (PGE2).

• Define the role of intermittent hypoxia as a macrophage tumor modulator in cells type RAW and the link generated in the COX-1 and 2 mediated for the synthesis stimulation of PGE2 during tumor progression.

• Prepared scientific reports, write and review manuscripts, and present research findings at scientific meetings. Medical Laboratory Scientist – MEDITEC – Tijuana, Mexico 09/2010 to 07/2013 Collect and prepare specimens and perform laboratory procedures used in the diagnosis, treatment and prevention of disease. Verify, record and report lab results on all performed tests. Ensure compliance with government requirements, hospital policies and laboratory procedures, including maintaining the cleanliness of lab equipment, instruments and work area.

• Executed and analyzed test in areas including chemistry, hematology, urinalysis, serology, histology and bacteriology.

• Performed quality control, maintenance and troubleshooting protocols to ensure proper.

• Observed proper handling of specimen and safe disposal biohazard waste.

• Performed manual dilutions on chemistries and manual verifications if outside linearity.

• Operated and calibrated an assortment of laboratory/testing equipment and performed various chemical, microscopic and bacteriologic tests.

• Documented all maintenance and technical problems per established protocol.

• Inventories and notifies the supervisor when supplies need to be ordered.

• Followed general hospital and laboratory policies/ regulations as related to professional behavior, dress code, punctuality, documentation, performance criteria, safety, privacy, and infections controls at all times. Education & Training

Bachelor of Sciences, Major Degree: Pharmaceutical Chemist 2006 - 2010 Universidad Autonoma de Baja California, UABC - Mexico Master of Science: Biomedical Engineering 2013 - 2015 University of Barcelona, UB – Spain

Certifications 2016

Six Sigma Green Belt, CSSGB – American Society for Quality, ASQ



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