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Contact Info
Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Quality Engineer


Reference:JOM AKWK-626560 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

Reference JOM AKWK-626560

Quality Engineer

Dun Laoghaire, Dublin

Main Responsibilities:

  • Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements;
  • Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue;
  • Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate;
  • Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases;
  • Liaise with relevant personnel regarding flow of product through QC department and other issues that arise;
  • Review, analyse and report on relevant customer complaints and institute corrective actions
Experience:
  • At least 3 years previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
  • Degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
  • Statistical Process Control
  • Six Sigma methodologies (Greenbelt Certification would be advantageous).
  • CAPA system management
  • FDA requirements and managing FDA audits.
  • Good knowledge of SAP and Track wise
  • continuous improvement projects e.g. Project Win SPC, automated machine.
  • Process validation
  • Clean room environment.
  • Cross functional team
  • Excellent interpersonal and communication skills
  • High level of computer literacy.



Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.


Contact Joan O’Malley at 087-1897333 for more details.