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Principle Quality Engineer - Complaints

Job description

Principle Quality Engineer – Complaints

Work with Ireland’s second largest employer and one of the world largest medical device companies as part of the post market surveillance team in the fast-growing Galway site. You will act as an SME for the site in this role helping to improve product quality and customer satisfaction. This site is heavily focused on NPI and NPD projects so you will be exposed to the newest and most exciting products available.

Responsibilities:

  • Act as a high point of leadership and knowledge for the post market surveillance site, developing excellence processes for investigations which are highly compliant with 21 CFR 820, ISO13485, MDD and MDR regulations.
  • Develop and implement quality engineering methods, systems and protocols to improve awareness and communication of quality initiatives and to drive continuous improvement for medical device quality.
  • Lead QMS Improvement Projects using your specialized knowledge of post market surveillance and problem-solving techniques.
  • Will have overall responsibility for Complaints projects including managing stakeholders and acting as point of leadership.
  • Act as internal and External SME for important matters relating to policies, projects and objectives relating to Quality Engineering and Post Market Surveillance.
  • Work cross functionally onsite regarding the Post Market Quality Assurance organisation and acquisition sites by partnering with Quality Operations, Design Assurance, R&D and Supplier Quality.
  • Use your strong knowledge of product design, manufacturing and product functionality to advise others onsite.
  • Review structural heart product design.

 

Requirements:

  • Level 8 degree in STEM subject with 8 years or more experience in medical device or highly regulated environment.
  • Strong knowledge of medical device regulations and dealing with complaints.
  • Travel occasionally for applicable projects.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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