VÍCTOR GÓMEZ
Summary
Professional in chemistry with 10+ Years’ experience in Medical Device Class I, Class II and Class III. Experience in Quality Engineering Process, 4+ Years’ Experience with Product Transfer from Germany/ USA to Mexico.
Overview
11
11
years of professional experience
Work History
Validation engineer
Merit medical
10.2024 - 02.2025
- Validation engineer consultant participating in a remediation program for the FDA at Merit Medical Pearland, TX.
- Creation of TMV protocol, report and executing TMV’s both attribute and variable, analyzing data and update several documentation as PFMEA, Quality plan, SOP’s and overall quality documents.
- Participating in management meetings to discuss the next steps of the project and give them feedback about the current process to improve their practices.
Quality Engineer
Insulet Corp
01.2022 - 12.2022
- Medical device consultant quality engineer based at MA Insulet corporation, in charge of creation of Work instructions and develop client process validation. Actively participate in cross functional teams to investigate root cause and correction actions for the problems associated with the Manufacture of the medical device (NCMR and CAPA).
Operations Quality Coordinator
Ontex Global
09.2021 - 02.2022
- Direct all activities related to ensuring the quality of the processes within the company, analyzing, and designing improvement plans that resolve the errors detected. NCMR and CAPA owner. Quality lab responsible and creator of SOP’s and all quality documentation.
Quality Engineer
Providien
07.2019 - 08.2020
- In charge of transfer of new products. Leading quality at production floor, in charge of 7 Quality engineers. Execution of TMV, Creation of PFMEA, Control Plans, SOP’s, Quality Techniques, review and approval of protocols and reports of IQ, OQ and PQ validations. Material Review Board, Engineer change orders, NCMR’s and company reduction costs responsible.
temporary Quality Engineer
DJO Global
09.2018 - 07.2019
- Involve in the reduction of GDP of molding, customer complaints system and generate Parameter setup sheet of all the machinery, contribute to the FDA audit as a support in documentation such as DHR review. Reductions of NCMR’s through Oracle system.
Lead Quality Assurance Engineer
Foxconn Medical division
01.2018 - 09.2018
- Responsible for Quality Process documentation creation and execution such as: Test Method Validation protocols and reports, FMEA, Advance Quality Plans and Standard Operation Procedures.
- Responsible for Quality Process documentation creation and execution such as: None Conformance Material Reports (NCMR), Complaints, CAPA, Supplier CAPA, Risk Management, Process Validation, Environmental Monitoring. Responsible for IQ and OQ protocol and report review and approval.
Quality Engineer
Markwins International
04.2017 - 11.2017
- Introduction of new Cosmetic products (NPI), performing IQ’s, OQ’s PQ’s. CAPA’s & NCMR participation, investigation and development. Document creation and control for company’s QMS in order to align current manufacturing practices with international standards and federal regulations. Controls the processing and archiving of test records. Capacitation and training records of all personnel of the company. Internal Audits.
Lab Supervisor
Nypro Healthcare Baja
09.2015 - 02.2017
- Responsible of the transfer of J&J tester machines of blood and Serum from Heidelberg, Germany and Rochester, NY. Train of the lab engineer in how to operate the machines to qualify them in quality trials. Execution of IQ’s and PQ’s validations.
Lab Supervisor
Medtronic
09.2015 - 09.2015
- Responsible for Physicochemical and microbiological analysis of raw materials and manufactured medical devices product.
- Responsible for quality assessment of water treatment systems
- Responsible for medical device sterilization (Auto clave, Ethylene Oxide gas and glutaraldehyde analysis and evaluation.Technical writing and deployment of Quality Systems documents such as SOP, WI, PROC, ER, CO, NCMR, PFEMA, IQ, OQ and PQ execution for Laboratory equipment.
Chemistry Teacher
PFLC (High school) and ITT (University)
01.2014 - 01.2015
- Classes of Chemistry I and II at PFLC of the junior class and Sustainable development at TEC of the Industrial Engineers class of the 6th semester.
Chemist
Public Security of the State of Baja, medical-toxicological department
09.2013 - 01.2015
- Performs immunoassay testing on urine specimens, point of care testing on urine and blood specimens for routine medical office needs and processes urine toxicology samples for transport to outside labs for confirmation of further testing.
Education
Master in Science - undefined
01.2013
Biopharmaceutical Chemist - undefined
01.2010
Skills
- Quality
- Manufacturing
- GDP/GMP
- English
- NPI Transfer
Accomplishments
- SPC certification with Minitab in 2019
- ISO 13485:2016 Internal audit by MIR in 2018
Publications
- Poly (Methacryloyloxy-o-Benzoic Acid) as Drug Carrier for Controlled Release publication date Jun 5, 2014 publication description Journal of the Mexican Chemical Society.
- Temperature- and pH-sensitive core-shell nanogels as efficient carriers of doxorubicin with potential application in lung cancer treatment publication date July 11, 2017 publication description International Journal of Polymeric Materials and Polymeric Biomaterials.
Training
- Workshop at Johnson & Johnson, Rochester, NY, NPI VITROS analyzers in 2016
- Workshop at Johnson & Johnson, Heidelberg, Germany, VITROS analyzers in 2015
Languages
English
Advanced (C1)
Timeline
Validation engineer
Merit medical
10.2024 - 02.2025
Quality Engineer
Insulet Corp
01.2022 - 12.2022
Operations Quality Coordinator
Ontex Global
09.2021 - 02.2022
Quality Engineer
Providien
07.2019 - 08.2020
temporary Quality Engineer
DJO Global
09.2018 - 07.2019
Lead Quality Assurance Engineer
Foxconn Medical division
01.2018 - 09.2018
Quality Engineer
Markwins International
04.2017 - 11.2017
Lab Supervisor
Nypro Healthcare Baja
09.2015 - 02.2017
Lab Supervisor
Medtronic
09.2015 - 09.2015
Chemistry Teacher
PFLC (High school) and ITT (University)
01.2014 - 01.2015
Chemist
Public Security of the State of Baja, medical-toxicological department
09.2013 - 01.2015
Master in Science - undefined
Biopharmaceutical Chemist - undefined
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