Overview

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

  • Support manufacturing areas to achieve targets.
  • Implement corrective action on issues as they arise.
  • Disposition NC’s, conduct & determine root cause analysis including corrective actions.
  • Conduct area GMP/GDP audits and follow up on findings to ensure satisfactory closure.
  • Follow up on corrective actions for in-process and customer complaint issues.
  • In-process sampling and testing and subsequent report writing.
  • Conduct First Article Inspections on product as required.
  • Conduct process audits against Quality System requirements.
  • Support all QA related documentation activities (i.e. Raise Change plans, write procedures etc)
  • Support functional area validation activities.
  • Support fault analysis and scrap reduction activities.
  • Participate/drive quality improvement projects/activities.
  • Participate in preparing & on-going maintenance of FMEAs and control plans.
  • Reporting function Quality metrics.
  • Have a basic knowledge of ISO/FDA/MDD and other product development related regulatory requirements
  • Have an understanding of standard metrology good practice.
  • Provide support for internal and external audits to ISO and FDA requirements.
  • Support prototype/manufacturing Operations area projects and initiatives i.e. Kaizen, CFPS etc.
  • Other tasks as directed by the functional area Quality Technician / Engineer in line with company goals and objectives.
  • Ensure all recording and cleaning logs are reviewed and approved per schedule
  • Work closely with all BE department to support completion of validation and process development projects
  • Carrying out investigations on product failures and customer complaints, reporting Non-Conformities and Out of Spec Results to the Quality Control Manager and Production Manager.

EDUCATION:

  • Third level qualification in Science, Engineering or equivalent.
  • Working knowledge of cGMP and ISO standards relevant to Quality Control procedures, documentation and testing.

 

EXPERIENCE:

  • One year previous quality experience in a similar work environment is essential.

 

For More information please call Sean on 0879221136 or email your CV to [email protected]

Sean Winstanley

Senior Technical Recruitment Consultant

Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.

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