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Quality Manager/Responsible Person

Location: Dublin
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Quality Manager/Responsible Person
Our client, a speciality pharma company, are currently recruiting for a Quality Manager to join their team on a permanent basis. Our client have added a new medical device product to their portfolio and require a Quality Manager experienced working with medical devices and MDR as well as having GDP/RP/Deputy RP experience. This role is based in Dublin city centre with hybrid working.


  • Buildingand maintaining a Quality Management System
  • Continually maintaining audit-readiness of the Quality System
  • Assisting in planning the internal audit schedules
  • Handling complaints and processing post-marketing requirements for medical devices within the specified timelines (and ensure company complies with post-market surveillance and reporting obligations)
  • Conducting corrective and preventative actions, updating the CAPA log and reporting the progress of the CAPA at scheduled quality and Annual Management review meetings
  • Leading Supplier Management activities including supplier evaluation and maintaining an approved vendor listing
  • Supporting on site audits of critical suppliers
  • Handle and maintaindocumentation supporting MDR, ISO and GDP standards
  • Managing warehouse and logistics including liaising with relevant company personnel ensuring receipt of regular inventory reports.
  • Assisting in generating Quality Documentation, new SOPs etc
  • Completing incoming inspection on Raw Materials
  • Carrying out Risk Assessments and managing change controls
  • Managing and monitoring training via ETQ. Managing and maintaining training files
  • Completing final batch release approval including checks on batch documentation received from CMO
  • Be point of contact for CMOs and distributors. Provide pro-active support for subcontractors strategically leading and directing to ensure key deliverables are achieved on time. Developing and maintaining a relationship to ensure a clear oversight of subcontracted responsibilities
  • To act as the main point of contact with competent authorities and notified bodies
  • Ensure Technical documentation and EU documentation of conformity are generated and up to date
  • Maintaining up to date design and development documents
  • BSc in Life Science/related Discipline
  • Experience working with Quality Management Systems
  • Experience working with Medical Devices and knowledge of MDR
  • Experience working as an RP or Deputy RP
For more information please contact Sinéad Cullen on +353879500821 or


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