Senior CAPA Specialist

Job Overview

Would you like to work for a company that produces products that both enhance and saves lives?

An excellent opportunity has arisen for a CAPA Specialist to join rapidly expanding US med-device company in Cork. This employer of choice offers fantastic career progression as well as a very attractive salary & benefits package.


As CAPA Specialist you will work within the QMS team with the remit to ensure compliance to CAPA processes and procedures.
Some of the key elements of the role will include:

· Responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity 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.

· 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.

· Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems.
· Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.

You will be degree qualified and have a minimum of minimum of 2 years' experience in quality systems or engineering or equivalent experience with 4 years + experience in a regulated environment.
You will be experienced in interacting with regulatory agencies and have a thorough knowledge and understanding of US and International Medical Device Regulations & be well used to supporting Quality Systems (e.g. Audits, Management review, Quality Planning).


As CAPA specialist you will work in a cutting edge world class manufacturing environment where the demands are great but where there is huge opportunity to progress your career and advance your technical expertise with a company that put a premium on talent development and employee engagement.
You also get the opportunity to work with a company that enhances patient's lives globally with an extremely competitive salary and benefits package that includes pension, healthcare, bonus & educational assistance.


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Or if you just have some questions about the job or want to have a chat call Feargus on 086 020 2554 or connect with me on or

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