Senior Quality Engineer - Complaints and CAPA

Jan 07, 2021
Feb 06, 2021
Blaine McKeever
Jobseeker Type
Organization Type
Contract Type
Full Time

Senior Quality Engineer, Complaints and CAPA, rapidly expanding Medical Device company, Galway City

My partner is an international medical device company who has just recently launched their innovative medical device in the United States to great success. They are seeking to follow up the fantastic launch with more products and planned design changes this year. On that basis, we need a Senior Quality Engineer Professional to join the team.

The focus is on the Complaints and CAPA aspects of the Quality System - ensuring that they are compliant with relevant international regulations and standards.

This isn't a monster multinational where you have lots of red tape and slow cross departmental communication. Communication will be fast - enabling you to do your job with as minimal bureaucratic nonsense as possible. A competitive salary package is on offer here paired with working flexibility. As the company is set to explode in 2021, it's a really great time to join and forge your path within the company with strong professional development opportunities along-side the company growth.

What will you do?

  • Ensure Complaints and CAPA systems are compliant with relevant regulations, standards and directives
  • Ensure the Complaints Investigation Laboratory is maintained and equipped to appropriately decontaminate and investigate technical complaints
  • Collaborate with other CAPA owners as required
  • Generate monthly reports and provide relevant data to RA for PMS purposes
  • Act as Complaint and CAPA Subject Matter Expert for external regulatory body audits

What do you need?

  • Minimum of 5 years relevant quality assurance experience within manufacturing for the Medical Devices industry (class III device experience prefered)
  • Experience with Quality Systems - Complaints and CAPA focused
  • Technical competency in the following:
    • ISO13485:2016
    • ISO14971
    • FDA CFRs
    • Class III Medical Device requirements

For more information please send a recent copy of your CV on a MS Word document to Blaine McKeever or call using the details listed and the ext. 3505. Successful candidates will be contacted immediately, and presented with current vacancies.

Not quite the right position for you? Do you know of someone who this could be more suited for? NonStop offers a referral fee for every candidate successfully placed so please do share this advertisement on with anyone who could be interested in positions in Ireland.

Nonstop Recruitment is a recruitment consultancy with fully licensed and staffed offices across Europe. We are renowned for professionalism, unrivalled industry knowledge and extensive candidate networks. The service our multinational, multilingual teams provide is underpinned by an in-house Quality Assurance team, something unique in our industry. Contact us for more opportunities.

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