Job Description

We are currently working a dynamic and driven medical device organisation who can boast having the leading technology in their field. Due to the continued progression and development of the business they are looking for a Quality Manager to join their team to that will be tasked to continue the tight control and development of their Quality Management Systems

The main responsibilities of this role will include:

  • Develop purchasing specifications

  • Approval of incoming material certificates process

  • Maintain quality records and sterilisation records including bioburden

  • Suggest improvements to the quality system and assist in its development

  • Deputise for the QA and RA Director where permitted by procedures

  • Manage the Quality Engineers

Day to day running of:

  • quality management system in line with documented procedures

  • CAPA system in line with documented procedures

  • complaints system in line with documented procedures

  • auditing system in line with documented procedures

  • validation system in line with documented procedures

  • non-conformance system in line with documented procedures

  • supplier approval and monitoring system in line with documented procedures

  • Issue Quality Alerts in line with documented procedures

  • Responsible for cGMP training for all employees

  • Attend Material Review Board (MRB) meeting

  • Attend Audit Planning Committee meetings

  • Attend Change Control Committee meetings

  • Chairing monthly and annual Management Review Meetings

  • Conduct all activities in accordance with ABHI, Eucomed and Company policies with particular regard to Healthcare Compliance and Bribery Act regulations.

To be considered for this position individuals will need to have at least 5 years quality assurance experience within the medical device sector. Ideally you will need to have experienced managing or leading a small team and be accustomed to reviewing, improving and managing quality management systems.

To be successful within the business you will need to demonstrate excellent communication skills and past experience managing both internal and external audits.

 
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