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Quality Assurance Specialist

2 weeks ago

Limerick, Limerick, Ireland Cook Medical Incorporated Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist 2 to join our team at Cook Medical Incorporated.

This role is responsible for providing quality assurance support as required within the company, including completing internal audits and maintaining the internal audit system, providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action program, and assisting in the implementation and improvement of all aspects of the quality management system (QMS).

Key Responsibilities
  • Maintain an active oversight of the QMS to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice.
  • Maintain the internal audit system in CMEU, acting as the Quality Internal Auditor with a team of Internal Auditors.
  • Conduct in-depth internal audits of all aspects of the QMS against the relevant regulations, and work collaboratively with relevant stakeholders to achieve zero non-conformances within CMEU.
  • Maintain a detailed and up-to-date knowledge of medical device regulations, guidance and requirements relevant to Quality Assurance.
  • Organise and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits.
  • Provide Quality Assurance support to all areas of the QMS, ensuring compliance is maintained at all times.
  • Identify, lead and drive QA process improvement initiatives as appropriate.
  • Prepare, implement and analyse key Quality Systems related documentation.
  • Maintain and support to the Corrective and Preventive Action (CAPA) program.
  • Maintain and support the Non-conformance program.
  • Delegate for the Manager, Quality Assurance, CMEU.
  • Provide training on the CMEU Quality Manual and other key Quality Systems procedures as required. Provide inputs to KPI's and Management Review.
  • Prepare Management Review presentations as appropriate.
  • Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.