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.

THE ROLE:

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.

THE FIT:
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).


WHATS IN IT FOR YOU?

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.

INTERESTED?

To apply, click the button!
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 http://bit.ly/2aNqmls or https://twitter.com/FeargusYoung




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