Oneika Stennette Email & Phone Number | I'm a Medical Device Reporter who has almost eight years in the industry. Some of my experiences includes Running Medical Device query reports on daily, weekly basis for quality review to determine if product complaints meet FDA requirements per policy and procedures. Submit medical device reports for timely submissions to the FDA. Perform report investigations to assure proper closure of product complaints. In charge of identifying cases considered to be as a potential cyber security breach for complaint handling department. Prepare spreadsheets uploading information and sending cases to the Cyber Security Team for final investigation review. Review and evaluate report investigations to assure proper processing have been performed for Complaint Closure cases. Tracking and monitoring Crystal reports from Smart Solve database ensuring all are completed on a daily basis and in compliance with the FDA. Ensures complete and accurate maintenance and reporting of Medical Device Report(s) or adverse action reaction data as required by regulatory agencies. Assist in CAPA processing. • Highlights: Assigned task for training and development to Team India MEIC training engineers on Review, MDR and Supplemental for remediation process.

Oneika Stennette

I'm a Medical Device Reporter who has almost eight years in the industry. Some of my experiences inc...
Los Angeles, California, United States

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Oneika Stennette’s Location Los Angeles, California, United States

Oneika Stennette’s Current Industry Olympus Corporation Of The Americas

Oneika Stennette’s Prior Industry Medtronic | Wells Fargo Home Mortgage | North Los Angeles County Regional Center | Ur Capital

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Global MDR Submissions Analyst II

2022-07-01 00:00:00 - Present

Associate MDR Vigilance Specialist

2014-07-01 00:00:00 - 2022-07-01 00:00:00

Bankruptcy Analyst

2012-01-01 00:00:00 - 2013-01-01 00:00:00

Secretary

2001-07-01 00:00:00 - 2009-06-01 00:00:00

Office Manager

2022-06-01 00:00:00

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Oneika Stennette is a I'm a Medical Device Reporter who has almost eight years in the industry. Some of my experiences includes Running Medical Device query reports on daily, weekly basis for quality review to determine if product complaints meet FDA requirements per policy and procedures. Submit medical device reports for timely submissions to the FDA. Perform report investigations to assure proper closure of product complaints. In charge of identifying cases considered to be as a potential cyber security breach for complaint handling department. Prepare spreadsheets uploading information and sending cases to the Cyber Security Team for final investigation review. Review and evaluate report investigations to assure proper processing have been performed for Complaint Closure cases. Tracking and monitoring Crystal reports from Smart Solve database ensuring all are completed on a daily basis and in compliance with the FDA. Ensures complete and accurate maintenance and reporting of Medical Device Report(s) or adverse action reaction data as required by regulatory agencies. Assist in CAPA processing. • Highlights: Assigned task for training and development to Team India MEIC training engineers on Review, MDR and Supplemental for remediation process.

Oneika Stennette has prior
experience in the following industries:
Medtronic | Wells Fargo Home Mortgage | North Los Angeles County Regional Center | Ur Capital

Oneika Stennette has the following professional experience:
Olympus Corporation Of The Americas | Medtronic | Wells Fargo Home Mortgage | North Los Angeles County Regional Center | Ur Capital