Medical Device Quality Manager

3 days ago


Limerick, Limerick, Ireland Life Science Recruitment Full time

We're currently recruiting for a Senior Quality Engineer to join our Medical Device organization based in Limerick. This is an exciting opportunity for anyone who is looking to join a leading multinational company.

About the Role
  1. As a Senior Quality Engineer, you will be responsible for reviewing/analysing the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  2. You will also review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
  3. Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
  4. Conduct periodic line audits to assess for production controls such as lot segregation.

This is an excellent opportunity for anyone who is looking to join a leading multinational company and be part of a dynamic team.

Responsibilities
  1. Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  2. Review/analyse whether current product and processes are in compliance to standards such as the QSRs, ISO 13485, etc.
  3. Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements).
  4. Conduct periodic line audits to assess for production controls such as lot segregation.


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