Description
An exciting opportunity has opened up for a Validation Engineer to join a leading fast paced Medical Device company based in the South West of Ireland.Principal Duties and Responsibilities:
Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements of ISO13485.
Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice.
Provide training and guidance to others on validations as required.
Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control.
Effective and efficient execution of validation and other projects:
Achieve key project deliverables on time and within budget Champion structured approach to problem solving within the organisation using cross-functional teams and six - sigma methodology.
Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
Project manage and lead cross functional teams with responsibility for the introduction and validation of new processes/new technology.
Work with equipment vendors to mutually understand their and our technical process challenges to improve capability, eliminate cost and improve effectiveness of validations.
Maintain the plants calibration system and equipment calibrations as assigned.
Investigate, trouble shoot, disposition and report on validation failures, system failures, non conforming products and other product defects.
This is an immediate position with competitive rates. If you would like to apply for this positon please contact Sarah Irvine on or alternatively apply to this advert with a copy of your CV.