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Eddie Byamungu , Bsc(Hons), Msc

Open for a new opportunities in Quality Assurance /Regulatory Affairs

Looking for a new Job in Quality Medical device

London, United Kingdom

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Eddie Byamungu , Bsc(Hons), Msc's Email Addresses & Phone Numbers

Eddie Byamungu , Bsc(Hons), Msc's Work Experience

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Open for a new opportunities in Quality Assurance /Regulatory Affairs

November 2015 to Present

PerkinElmer, Inc.

Quality Assurance Engineer Management Representative

August 2014 to October 2015

London, United Kingdom

Medicom Healthcare

Quality Assurance (Freelance)

June 2014 to August 2014

Eddie Byamungu , Bsc(Hons), Msc's Education

The University of Hull

Master’s Degree Biological and Biomedical Engineering

2008 to 2010

The University of Northampton

Bachelor degree General Engineering ( Electronic Mechanical & Manufacturing )

2004 to 2008

Bwindi Technology institute

High School Science

Eddie Byamungu , Bsc(Hons), Msc's Professional Skills Radar Chart

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Empathetic
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Eddie Byamungu , Bsc(Hons), Msc's Estimated Salary Range

About Eddie Byamungu , Bsc(Hons), Msc's Current Company

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Eddie Byamungu , Bsc(Hons), Msc works in the Medical Devices industry.


About Eddie Byamungu , Bsc(Hons), Msc

📖 Summary

An experienced Medical Device Quality Assurance & Regulatory Affairs professional with experience in Performing Audits ( Internal and external), Maintaining the Quality Management System in compliance with ISO 13485,21 CFR 820 and other ,Product Registration ,Managing Non Conformances ,CAPAs and liaising with Regulatory AuthoritiesOpen for a new opportunities in Quality Assurance /Regulatory Affairs @ From November 2015 to Present (2 months) Quality Assurance Engineer Management Representative @ •Act as the site Quality Representative for the UK site. Maintaining the Quality Management System in compliance with ISO 9001:2008 & ISO 13485 and 21 CFR 820 (FDA). •Managing the Customer Complaints, CAPAs, Non-conformances& Supplier Correction action •Support the Design Team when conducting the Risk Management( ISO 14971) •Performing Internal to ISO 9001 /ISO 13485 and 21 CFR 820 & Supplier Audits and hosting the Notified body audits. •Checking Incoming Products and consulting with suppliers regarding defecting products. •Working closely with Production on rejected/Quarantine products and maintaining the calibration and the maintenance of equipment •Managing the training files by liaising with Department’s Managers and working closely with Software Development on IEC62304 (software medical device) From August 2014 to October 2015 (1 year 3 months) London, United KingdomQuality Assurance (Freelance) @ •Maintaining the Quality Management System in compliance with ISO13485 and Good Distribution Practise (GDP). •Participate to MHRA and Notified body ‘s (SGS) audits •Performing supplier Audits and drafting technical agreements with suppliers. •Managing supplier approved list (including the wholesalers) From June 2014 to August 2014 (3 months) Quality Assurance and Regulatory Affairs Manager ( freelance ) @ •Maintaining the Quality Management System in compliance with EN ISO13485 •Performing Internal audits •Managing Post-market Surveillance and Maintaining the product’s technical files From January 2014 to June 2014 (6 months) Watford, United KingdomQuality Assurance Engineer @ •Maintaining the Quality system in compliance with EN ISO 9001:2008 •Performing Internal audits to ISO 9001/ISO 13485 and Supplier Audits •Managing the supplier approved list and supplier’s Quality Technical Agreements •Supporting the preparation , execution and closure of Field actions (FSN ,FSCA) •Documenting non-Conformances and Correction and Preventing Actions (CAPAs) & liaising with suppliers regarding faulty products •Support the business at a EMEA level and interact with all countries in the region From March 2012 to November 2013 (1 year 9 months) Regulatory Affairs Executive ( 12 months contract) @ •Creating and submitting the product’s technical files for CE Marked and liaising with affiliates worldwide for international registrations. •Maintaining the Quality Management System in compliance with ISO13485, CAN/CSA ISO 13485(Canada) , FDA 21CFR 820 ,TGA (Australia), JPAL(Japan) and other •Performing Internal Audits and Participating to the authority audits (FDA,UL, Jpal) •Managing the product’s IFUs and labelling in compliance with MDD93/42 EEC From March 2011 to March 2012 (1 year 1 month) Master’s Degree, Biological and Biomedical Engineering @ The University of Hull From 2008 to 2010 Bachelor degree, General Engineering ( Electronic, Mechanical & Manufacturing ) @ The University of Northampton From 2004 to 2008 High School, Science @ Bwindi Technology institute Eddie Byamungu , Bsc(Hons), Msc is skilled in: ISO 13485's Lead Auditor training ( course conducted by Hospira inc in Chigaco), FDA 21CFR 820 Compliance Certificate(course conducted by Monarch Quality USA), IEC 62304 Software Medical Device (course conducted by Intertek)


Eddie Byamungu , Bsc(Hons), Msc’s Personal Email Address, Business Email, and Phone Number

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Eddie Byamungu , Bsc(Hons), Msc's Personality Type

Introversion (I), Sensing (S), Feeling (F), Perceiving (P)

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0 year(s), 10 month(s)

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