Medical Device Validator

2 weeks ago


Dublin, Dublin City, Ireland Matrix Recruitment Group Full time
About the Company:
Our client is a leading manufacturer of high-value packaging and components for the medical devices industry. With a proven track record in producing high-quality products, they are expanding their production facility to meet the demand for their products.

Job Description:
The role will operate on a Day shift Monday to Friday. You will report directly to the Quality Manager and be responsible for supporting all validation activities associated with the successful qualification of new tools. Key duties & responsibilities include:
  • Write and execute process validation protocols and report for new product introductions and revalidation due to process/material improvements.
  • Involved with the maintenance and support of compliance to ISO 13485 and ISO 14001 systems standards.
  • Incorporate solutions to sustain and improve the QMS.
  • Strong focus on continuous improvements through Lean Six Sigma methodologies.
  • Direct support and involvement in GMP and regulatory Audits.
  • Review and execution of Factory acceptance testing and site acceptance protocols.
  • Prepare and deliver training modules as required.
  • Support Continuous Improvement through Lean Six Sigma methodologies.

Required Skills and Qualifications:
To succeed in this role, you will need:
  • A third-level qualification in an engineering discipline or Polymer science.
  • 3 to 5 years' experience as a Validation Engineer in an injection moulding/medical device background.
  • Experience in statistical analysis (Minitab)/ SPC/ Validations is a must.
  • Possess the ability to be influential and proactive in their approach to their day-to-day duties.
  • Strong attention to detail and possess a hardworking competency.


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