HANNAH KIRBY
Ellenwood,GA
Summary
Experienced Quality Professional with 6 years of experience in conducting post market surveillance activities, adverse event reporting, identifying quality gaps and processes, and utilizing reporting systems that track quality performance, improvements, and trends.
Overview
8
8
years of professional experience
Work History
Complaint Handling Operations Investigator
Philips
11.2022 - Current
- Led a team of 3 in monitoring and evaluating customer complaints, adverse events and other post-market data for a portfolio of 7 oxygen therapy devices.
- Developed and delivered training to over 20 new complaint handling operations investigators and contract employees, leading to a reduction in complaint volume.
- Collaborated with cross-functional teams to resolve product issues resulting in the implementation of corrective actions and preventative actions.
- Working knowledge of global device regulations, requirements, and standards such as 21 CFR Parts 803, 806 and 820.
Quality Analyst
Philips
01.2017 - 11.2022
- Monitored, investigated, and reported on the performance of Philips oxygen devices.
- Analyzed customer feedback, service records, and other data sources to identify potential complaints.
- Reviewed complaint records, applied appropriate coding and summarized complaint investigations.
Quality Technician
Aerotek
06.2016 - 01.2017
- Ensured customer satisfaction by demonstrating a strong technical knowledge regarding Frontline brand products to resolve customer complaints and set product expectations.
- Complied with federal regulations by handling and documenting all Suspected Adverse Events, off-label inquiries and Product Quality Complaints.
- Utilized quality management software to accurately classify and document the necessary information used to generate all required regulatory reports.
Quality Associate
TRC Staffing Service
10.2015 - 02.2016
- Documented the receipt and condition of domestic and international Alcon contact lens products to effectively analyze and identify the required testing.
- Utilized Trackwise quality management software system to investigate and document customer complaints.
Education
Master of Public Health -
Mercer University
Atlanta05.2022
Bachelor of Science - Biology
North Carolina Agricultural And Technical State University
Greensboro05.2014
Skills
- Adverse Event Reporting
- Complaint Investigation
- Data Analysis
- Documentation
- Quality Management Software
- Microsoft Office Suite
- Regulatory Compliance
Timeline
Complaint Handling Operations Investigator
Philips
11.2022 - Current
Quality Analyst
Philips
01.2017 - 11.2022
Quality Technician
Aerotek
06.2016 - 01.2017
Quality Associate
TRC Staffing Service
10.2015 - 02.2016
Master of Public Health -
Mercer University
Bachelor of Science - Biology
North Carolina Agricultural And Technical State University
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