Judy Fedele
Burlington,MA
Overview
43
43
years of professional experience
4
4
years of post-secondary education
Work History
Receiving Associate
Burlington Coat
Billerica, MA
05.2011 - 04.2022
- unload trucks, process merchandise
Internal Audit Manager, ISO 13485
Instrumentation Laboratories
Bedford, MA
07.1978 - 04.2010
- Maintained and updated quality management system to facilitate procedure enhancements, revision changes and overall process control.
- Coordinated internal audit processes and scheduled internal audits with team.
- Reported audit findings to management within defined timelines.
- Identified management control weaknesses and provided value added suggestions for remediation.
- Developed and maintained approved Vendor list
- Track vendors on time deliveries and rejection
- Performed vendor audits in US and Europe
- Established electronic training records
- Prepared working papers, reports and supporting documentation for audit findings.
- Trained new employee on ISO 13485 standards
- Assisted with 510k filling to FDA for new instrument approval
Education
Bell County High School
Pineville, KY 01.1964 - 06.1968
Timeline
Receiving Associate
Burlington Coat
05.2011 - 04.2022
Internal Audit Manager, ISO 13485
Instrumentation Laboratories
07.1978 - 04.2010
Bell County High School
01.1964 - 06.1968