David Kiely Email & Phone Number

Auckland, New Zealand

Auckland, New Zealand

● Worked with cross functional teams to support the launch of multiple products in the Obstructive Sleep Apnea Homecare space.● Experience gained in Injection Moulding, Welding and Knitting and Textile Processes.● Leading the development of CI structure in NPI Quality Team and actively involved in multifunctional improvement projects centered around Process Validation, Risk Managment and New Product Implementation● Completed formal training to ISO-14971● Lead global improvement initiative using Six Sigma methodologies to improve the Process Validation process and associated procedures within the global QMS infrastructure

Cork Metropolitan Area

● Gained strong proficiencies in problem solving skills and mistake proofing skills in the production environment. Over this time I became a training facilitator for both ● Gained experience in batch release processes. Worked heavily to support Embolic Solution products● Utilized inventory management skills and decision making to material expiry and production non-conformances during lot processing of multiple UPNs on a single production line.● Gained proficiency in steam sterilization through in house processes.

Cork Metropolitan Area

● Was the lead Quality Engineer on a NPI project and led a successful product launch through Limited Market Evaluation before playing an essential role in full launch development.● Facilitated a number of continuous improvement ideas through development while maintaining ‘Quality First’ mindset and ensuring compliance to FDA Regulations and EUMDR.● Have gained strong knowledge of validation/verification (V&V) processes, OQ/PQ, PRA/PFMEA, Process Characterisation, Workstation Vulnerability Assessment and NCEP/CAPA Processes.

Courtmacsherry

County Limerick, Ireland

Bachelor'S Degree, Biomedical/Medical Engineering, First Honours

Activities and Societies: UL GAA

Bachelor Of Engineering - Be, Biomedical/Medical Engineering, First Class Honours

Leaving Certificate, 570

Activities and Societies: Student Council President (2015-2016)