Quality Engineer II

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    Full Time

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  • Published:

    8 days ago

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Job description

We are actively seeking experienced quality engineers who are ready to join a leading global manufacturer of medical devices in Tipperary.

Job Responsibilities: 

  • Identifying Manufacturing process defects (scrap, nonconforming material, customer complaints).
  • Finding the primary root causes and implementing CAPAs.
  • Developing Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation.
  • Quality lead on Production unit and quality process improvement projects.
  • Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
  • Auditor of quality system, such as development and manufacturing, as assigned
  • Key partner in forming and evaluating the production area strategy for the production unit.
  • Identify & lead quality projects to support Production Area Strategy.
  • Lead on Preventive Quality initiatives in Production unit.
  • Technical investigation and documentation of non-conforming events and trends.
  • Leads investigations on customer internal & external complaints.
  • Ensure Regulatory compliance in projects.
  • Analyse preliminary plans and develop reliable engineering programs to achieve company, customer and governmental agency reliability objectives.
  • Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
  • Leads process improvement efforts by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Job Requirements: 

  • Higher Level Degree qualification in Engineering/Quality/Science
  • 5+ years’ experience in a Medical Device environment or related industry.

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