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Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Quality Engineer


Reference:JOM AECP-463357 Location: Louth
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Engineer

JOM AECP-463357


Quality Engineer


Location Co Louth

RESPONSIBILITIES:

  • Manage and provide guidance on Data Strategies for Change Control process
  • Actively supports site CAPA system, mentors associates on CAPA process, co-ordinates preparation of data for CAPA review Meetings etc.
  • Actively supports internal audit program for the site and identify areas of potential noncompliance or improvements.
  • Be a key member of the onsite audit team during external audits, e.g. from Regulatory Authorities and Global Corporate Quality.
  • Assist and facilitate Complaint investigations ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Ensure appropriate Risk Management activities are completed at all stages of CAPAs, CAPA Initiation (CID), Complaints and Quality Notifications
  • Assist and co-ordinate the preparation of data for Management review Meetings for all products manufactured on site.
  • To actively support the development/implementation and continuous improvement of the Quality Management Systems.
  • Develop and write SOP & Controlled Documents.
  • Co-ordinate / generate quality metrics / reports for weekly meetings
  • Where relevant, take ownership of Corrective and Preventive Actions, and track progress through Trackwise or similar e-CAPA systems.
  • Training of associates on Quality procedures and initiatives

RELEVANT EXPERIENCE & EDUCATIONAL REQUIREMENTS
  • Degree Qualified in Engineering, Science or Quality related discipline.
  • 3+ Years relevant work experience in a regulated medical device or pharmaceutical environment.
  • Proven working experience with FDA QSR and ISO 13485.
  • Strong understanding of change and project management
  • Proven track record in problem solving, root cause analysis and supporting quality notification / CAPA resolution.
  • Ideally Qualified 'lead auditor' experience.
  • Six Sigma or similar statistical background would be advantageous
  • Experienced in technical writing and review
  • Experience in CAPA system management
  • Proven ability of working in a cross-functional team environment.
  • Excellent interpersonal and communication skills and high level of computer literacy.


Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. Contact Joan O’Malley at 087-1897333 [email protected] for more details.