Quality Engineer

  • Reference: CJ46448
  • Job Type: Contract
  • Location: Cork, Cork City, Munster
  • Category: Engineering, Technical & Manufacturing

Role Responsibilities:

 

  • Maintain and improve existing ISO 13485 quality management system
  • Lead CAPA related activities and associated tasks
  • Prepare for and document Management Review Meetings
  • Manage task completion, as they arise from Quality Meetings
  • Complete document approval and release activities in line with company procedures and systems
  • Complete day to day activities within an ISO13845 quality management system (calibration, training, etc.)
  • Support vendor management activities including critical vendors audits
  • Ensure that all activities are conducted pursuant to appropriate standards for completeness, accuracy and documentation conforms to company and regulatory expectations for safety, efficacy and compatibility with applicable industry standards

 

Desired Skills and Experience:

 

  • Degree qualified with a minimum of 2 to 3 years’ experience in medical device quality role
  • Knowledge and understanding of ISO 13485, 21CFR820 and MDD (93/42/EEC)
  • Understanding of medical device manufacturing processes and controls
  • Having contributed to major regulatory device submissions i.e. CE and 510(k)’s would be an advantage
  • Excellent problem solving, oral and written communication skills
  • Must be self-motivated and detail oriented
  • Ability to work as part of multi-disciplinary team of clinicians, engineers and senior management

 

For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email emer.ocallaghan@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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  • Emer O'Callaghan
  • Recruitment Consultant
  • 0214911061
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