Gloria Obregon Email & Phone Number | Quality Systems Professional with 18 years’ experience with IVD and medical devices. Areas of expertise include Document Control, Training, Quality Audits, Regulatory Inspections and Audits, nonconformities and Corrective and Preventive Action (CAPA). Lead Auditor with in-depth knowledge of FDAs 21CFR Part 820 & Part 11, ISO 9001, ISO 13485, ISO 14971, GMP, and the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Devices Regulation (IVDR). Leader recognized for interpersonal, problem-solving, decision-making skills and ability to influence change and lead teams.

Gloria Obregon

Quality Systems Professional with 18 years’ experience with IVD and medical devices. Areas of expert...
Chula Vista, Chula Vista, United States

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Gloria Obregon’s Location Chula Vista, Chula Vista, United States

Gloria Obregon’s Current Industry Artiva Biotherapeutics Biomerieux

Gloria Obregon’s Prior Industry Bangladesh | Quidel | Alere | Alere San Diego

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Sr. Manager Quality Operations

2023-09-01 00:00:00 - Present

Quality Assurance Manager

2021-04-01 00:00:00 - Present

Quality Assurance Specialist

2018-08-01 00:00:00 - 2019-04-01 00:00:00

Quality Assurance Manager

2017-10-01 00:00:00 - 2018-08-01 00:00:00

Quality Assurance Manager

2015-03-01 00:00:00 - 2017-10-01 00:00:00

Document Controller

2009-07-01 00:00:00 - 2011-09-01 00:00:00

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Gloria Obregon is a Quality Systems Professional with 18 years’ experience with IVD and medical devices. Areas of expertise include Document Control, Training, Quality Audits, Regulatory Inspections and Audits, nonconformities and Corrective and Preventive Action (CAPA). Lead Auditor with in-depth knowledge of FDAs 21CFR Part 820 & Part 11, ISO 9001, ISO 13485, ISO 14971, GMP, and the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Devices Regulation (IVDR). Leader recognized for interpersonal, problem-solving, decision-making skills and ability to influence change and lead teams.