Medical Device Quality Engineer

3 days ago


County Roscommon, Ireland Pale Blue Dot Recruitment Full time

Job Overview

We are looking for an experienced Quality Assurance Engineer to join our team at Pale Blue Dot Recruitment. The successful candidate will provide quality support to ensure customer and QMS requirements are implemented and fulfilled to required GMP standards.

The role involves leading quality engineering activities for the introduction of new product lines through development of product inspection plans, production documentation, process FMEAs and risk management plans.

  • Main Responsibilities:
  • Ensure change requests are effectively managed
  • Lead quality engineering activities for existing product lines through maintenance and continuous improvement of product inspection plans, production documentation, process FMEAs and risk management plans
  • Investigate root cause of quality issues and follow through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues
  • Oversee non-conforming material, customer complaints, CAPA investigations, analysis, and improvement
  • Utilize data analysis and trending, statistical process control, root cause analysis and implement corrective actions

About Our Ideal Candidate

We are looking for someone with a strong proficiency in statistical analysis techniques to investigate and solve problems and improve quality. You will also have excellent interpersonal skills, ability to work in a cross-functional team and possess project management training.



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