Senior Quality Assurance Manager

5 days ago


Limerick, Limerick, Ireland Cook Medical Full time

Job Summary:

We are seeking a highly skilled and experienced Senior Quality Assurance Manager to lead our team of Quality Control Inspectors in a production environment.

Main Responsibilities:

  • Ensure Quality Control of medical devices within Cook Medical, including inspection of raw materials, in-process product, finished and sterilized devices.
  • Develop and implement quality control procedures to ensure compliance with regulatory requirements.
  • Maintain excellent communication channels with the production team and other departments.
  • Work closely with other departments to meet delivery requirements.
  • Take ownership for assigned customer complaints, CAPA's and determine root cause.
  • Monitor rejects from quality control processes and disposition through MRB process.
  • Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.

Requirements:

  • Level 8 in Manufacturing Engineering or related discipline preferable.
  • Minimum 5 years previous experience in a supervisory position desirable.
  • Strong communication and inter-personal skills.
  • Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
  • Knowledge of Lean Manufacturing desirable.
  • Good computer skills including knowledge of Microsoft Office.
  • Excellent organisational and team building skills.
  • High self-motivation.
  • Willingness and availability to travel on company business.


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