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Vacancy Details


105788 - Quality Assurance Engineer - Limerick

Contract Type: Permanent
Location: Limerick
Date: 7/11/2019
Job Reference: 105788
Contact Name: Clara Burke
Contact Email:

Job Description

Quality Assurance Engineer - Limerick - 105788

Quality Assurance Engineer

Our client, a leading company in Limerick, Ireland is recruiting for an Quality Assurance Manager to join their team.

This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company’s corrective and preventive action program; and assisting in the implementation and improvement of all aspects of the quality management system (QMS).

Reporting to: Quality Assurance Manager

  • Maintain an active oversight of the CMEU QMS to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice.
  • Maintain the internal audit system in CMEU, acting as the Quality Internal Auditor with a team of Internal Auditors.
  • Conduct in-depth internal audits of all aspects of the QMS against the relevant regulations, and work collaboratively with relevant stakeholders to achieve zero non-conformances within CMEU.
  • Maintain a detailed and up to date knowledge of medical device regulations, guidance and requirements relevant to Quality Assurance.
  • Organise and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits.
  • Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times.
  • Identify, lead and drive QA process improvemen initiatives as appropriate.
  • Prepare, implement and analyse key Quality Systems related documentation.
  • Provide input and support to the Corrective and Preventive Action (CAPA) program.
  • Designee for the Manager, Quality Assurance, CMEU.
  • Provide training on the CMEU Quality Manual and other key Quality Systems procedures as required. Provide inputs to KPI’s and Management Review.
  • Prepare Management Review presentations as appropriate.
  • Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
The Ideal Candidate
  • Third Level qualification in Quality, Science, Engineering or other relevant technical discipline.
  • Proven knowledge and experience (min 4 years of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
  • Qualified and experienced Lead Auditor, preferably within the medical device industry.
  • Good working knowledge of Microsoft Office.
  • Strong interpersonal skills with the proven ability to communicate effectively at all organisational levels.
  • Demonstrable ability to challenge / influence thinking / opinion / actions with the aim of ensuring CMEU QMS is adhered to.
  • High attention to detail.
  • Excellent organisational skills and the ability to manage own time effectively.
  • High self-motivation, with a proactive, solution driven approach to problem-solving.
  • Willingness and availability to travel on company business.

For further information on this Quality Assurance Engineering role in Limerick please contact Clara Burke on 086-8168273/ 
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
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Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

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Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

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VP of Human Resources

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Orla Keady-Giblin,
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Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

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Valeo Vision Systems

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