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Details

Quality Specialist (Medical Devices)


Reference:CK/AOUD-132180 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: €40000 - €45000

12 Month Fixed Term Role

JOB SCOPE:

Reporting to the Quality System Manager you will join a team responsible for improving key Quality System processes including Internal Auditing, NCEs, DCOs, Batchcard / Release sheet review and internal training to staff and operators on quality issues. Provide QA support to manufacturing operations as required. Participate in projects in order to contribute to continuous improvements. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes.

KEY RESPONSIBILITIES:

To assist in managing the company quality system including the following:

  • Review and log NCEs and issue status reports as required. Manage NCE board presentation, minutes, actions as required. Provide support to personnel in raising NCEs including deviations.
  • Develop and undertake induction and routine quality training of new and current employees.
  • Provide Quality support to manufacturing Phase I & Phase II.
  • Complete Calibrations of gauging & Measuring equipment.
  • Review batchcard, release sheet and shipping documentation for completeness.
  • Update Standard Operating Procedures, Work Instructions and Quality Related Documentation as required.
  • To actively promote Quality in the Company and demonstrate a knowledge of GMP to internal and external stakeholders.
  • To assist in managing / coordinating the company quality system in line with regulations.
  • Any other duties as determined by the Quality Systems Manager.

EDUCATION, SKILLS AND EXPERIENCE:

  • Good level of technical and analytical expertise to assist in problem solving.
  • Third level science or engineering qualification background with relevant work experience in the medical devices sector.
  • Experience in a QA role or working to an ISO quality standard.
  • Good knowledge of ISO 13485, GMP and 21 CFR 820 an advantage.