Senior CAPA Specialist

Job Overview

An exciting new career opportunity for a Senior CAPA Specialist has opened with a global medical device client company in Cork.

THE ROLE: The Senior CAPA Specialist will work within the QMS team, under general supervision to ensure compliance to CAPA processes and procedures including:
* Responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectively and timeliness. * Review & Approval of CAPA changes including extension requests.
* Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
* Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
* As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
* SME on all related procedures, ensuring compliance to the relevant Corporate procedures. Super user of eCAPA system.

* As the ideal candidate you will hold a Bachelor's Degree in Engineering, Science or a related area with 4+ years experience in quality systems / engineering in a regulated industry

THE REWARDS: This a fantastic opportunity to further your career with a company who genuinely make a difference to people's lives globally. There is an extremely competitive base salary available along with a generous pension, bonus plan & healthcare cover for you and your dependents. You will also get the opportunity to work with a company where there is a well-established culture of promoting internally and where talent and dedication is recognised and rewarded.

Please click on the link to apply or if you would prefer to have an informal and confidential chat before applying please contact Leo Cordingley on 086 049 5443 Alternatively, you can connect or message me on LinkedIn at:

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