Operations Quality Engineer

MEDICAL DEVICES
MEDICAL DEVICES
Galway
Permanent
15820
Galway
Permanent
15820
Overview:

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*


Please contact Elaine Dolan for more information or a confidential discussion on

elaine.dolan@collinsmcnicholas.ie

091 706 718

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Elaine Dolan
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