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Quality Engineer

  • Location: Galway, County Galway, Connaught, Ireland
  • Job Type:Permanent

Position: Quality Engineer – Medical Device Organisation, Galway

Responsibilities (full job spec available upon request)

  • Identifies and resolves complex exceptions to work assignments.

  • Summarizes, analyses draw conclusions, and make appropriate decisions from test results or other process related findings.

  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of the non-conforming product.

  • Participates in Customer Complaints investigation for areas under their control.

  • Continually seeks to drive improvements in product and process quality.

  • Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making the appropriate decisions on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.

  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.

  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.

  • Knowledgeable on Risk Management, BSEN 14971 requirements.

  • Compiles and analyses operational, test, and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.

  • Uses knowledge of Six Sigma, Statistical Analysis, and Lean principles to investigate and solve problems and improve quality.

  • Gives technical guidance to Associate Quality Engineer, Technician, and Inspection staff.

  • Deals with suppliers, other engineering disciplines within and outside of the Site, and customers should the need arise.

  • Is familiar with the internal auditing process.

Qualifications and Experience:

  • NFQ Level 8 qualification in a STEM discipline

  • Minimum of 3-4 years experience in a Quality Engineering capacity.

  • Good technical capabilities, communication skills, teamwork abilities, and initiative.

*Strong benefits on offer such as full healthcare, pension, annual bonus*

For a confidential discussion on the role please contact Chris O Toole

091 706713