1. Brendan Naughton – Curriculum Vitae
10 Maigh Riocaird, Castlegar, Galway.
brendan_naughton@hotmail.com
(087) 1235017
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Personal Summary
A Quality Engineer with 9 years’ experience in the Medical Device Industry.
Experience in a large highly regulated multinational Medical Device Company and a
smaller independently run company. A broad level of Quality Assurance experience
primarily in the design, development and sustaining of class II/III medical devices as
well as manufacturing process review, SOP and test method creation and review,
incoming inspection and supplier quality, process and product validation. A proven
project team member and leader that operates with accountability, integrity and
embraces new challenges.
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EMPLOYMENT HISTORY
Steripack Ireland Apr 2014 - Nov 2014
Quality/Validation Contract Engineer
FDA Audit Preparation
Supported a variety of quality activities in preparation for the FDA audit.
• Completed procedure vs practice process reviews and associated procedural
updates for manufacturing processes, packaging processes and in process
testing procedure.
• Completed a review and update to the calibration SOP in collaboration with
the Engineering manager.
• Created and gained approval of Gauge R&R SOP.
Quality Engineer - Incoming Inspection
Provided cover for Incoming Inspection.
• Completion of incoming inspection testing for all incoming material and
reconciliation for product returning from Sterilization
• Raise NCEs and SCAR’s for non-conforming material, liaising with the
suppliers to identify root causes
Quality/Validation Engineer
A member of the Validation Quality Team with responsibility for planning, creation,
review and approval of validation documentation and associated activates.
• Creation and approval of PQ protocol and approval of report for a Headerbag
Pouch
• Creation and release of PFMEA for Headerbag Pouch machine.
• Provided support on the Print Press PFMEA and the Laser PFMEA.
• Creation and approval of Ranging Study for Pouch.
• Creation and approval of Gauge R&R study on in process inspection rulers.
• Analysis of Statistical Data for Transition Tyvec project.

2. Boston Scientific Ireland Sep 2003 - Dec 2003
Feb 2005 - Oct 2013
Quality Engineer Nov 2008 – Oct 2013
Design Assurance, Sustaining Engineering
The Sustaining Engineering function within Boston Scientific has responsibility for
maintaining all of the current products on the market. The primary activates include
periodic review of the product design history against internal and external
requirements, execution of design changes, complaints reviews and non-conforming
event investigation.
• Planned and executed a range of thorough product reviews to identify gaps
against internal requirements and applicable regulatory requirements.
• Co-ordinated device and packaging design changes from draft proposal
through to implementation, including working the other functions to ensure all
deliverables were completed as required.
• Completed Design Verification, Design Validation, Shelf Life, and
Environmental studies, including creation of protocols, testing co-ordination
and report writing, including statistical analysis.
• Test Method and Data Sheet creation and validation.
• Created and maintained Product Risk Analysis documentation, including
Design and Use FMEA, User Flow Charts, post-market surveillance, usability,
product field assessment, including applicable complaint analysis.
• Reviewed Technical Files and Design Dossiers for completeness and
accuracy in relation to Design Verification, Design Validation, Risk
Management and relevant standards.
• Complaints review and associated investigations to address any unacceptable
increase in complaints rates.
• Initiated and completed investigations into non-confirming events for both
product and system non-conformances.
• Completed the functional deliverables associated with the discontinuation of
products that had come to end of life.
• Internal site to site transfer of Product Design ownership.
• Pre-Audit preparation and live audit support.
• Supported senior staff with responses to audit questions resulting from annual
compliance audits.
Quality Technician Oct 2005 – Nov 2008
Design Assurance Mechanical Test Lab
The Design Assurance Mechanical test lab has responsibility for supporting and
completing the product testing associated with the Design and Development of
Boston Scientifics new products. As test technician I completed the following activities
• Mechanical and analytical product testing in support of Feasibility Studies,
Test Method Development, Test Method Validation, Pre-Design Verification
studies and Design Verification studies.
• Provided training to other test technicians.
• Test method/Data sheet development and enhancement.
• Relocation of test equipment as part of the Design Assurance Lab move.

3. Product Builder Sep 2003 – Dec 2003/ Feb 2005 – Oct 2005
I have completed two periods of employment as a product builder with Boston
Scientific. In 2003 I worked on the coating lines of the first Drug Eluting Stent
developed in the Galway site. I returned in 2005, following a year travelling Australia,
where I worked on the assembly of the stent delivery balloon catheters and then on
the assembly of one of the coronary balloon catheters.
University of Glamorgan Students Union July 2002 – June 2003
Union Secretary
I was elected to the position of Union Secretary during the final year of my studies. As
Union Secretary I had responsibility for the democracy within the student union, the
student magazine, communications with the student union and sat on a number of
university committees. During my time as Union Secretary I achieved the quorate
requirements for all student union meetings, something that had not been achieved in
over 10 years.
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EDUCATION AND QUALIFICATIONS
2007 - Higher Diploma in Quality Assurance Awarded 2:2
NUI Galway
Galway.
2002 - BSC Forensic Science Awarded 2:2
University of Glamorgan,
Treforrest, Pontypridd, Wales.
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IT Skills: Microsoft Office, Microsoft Excel, Microsoft Powerpoint, MiniTab
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REFERANCES: Available upon request