Senior Quality Assurance Engineer – Galway | Collins McNicholas

Senior Quality Assurance Engineer – Galway

  • Reference: GJ41909
  • Job Type: Permanent
  • Location: Galway, Galway City, Limerick
  • Category: Engineering, Technical & Manufacturing

Responsibilities:

  • Establishing inspection standards, plans, frequencies and test methods.
  • Preparing and approving procedures, routing set-up’s and shop floor documentation. Generate and approve change requests
  • Preparing/Reviewing Master Validation Plans, FMEA’s, and Control Plans.
  • Make appropriate decisions on a daily basis.
  • Addressing customer complaints and getting to source of the issue
  • Process owner of NCR process – getting to source of the issue and implementing CAR.  Ownership of driving this process for assigned projects.
  • Drive continuous improvement and innovation from a quality perspective.
  • Performing an active role in further development of the quality management system. This will involve:
    • Performing internal audits to ISO and FDA requirements.
    • Upgrading system elements as appropriate.
  • Work with suppliers and customers on the resolution of product quality issues and quality improvement programs
  • Quality representative on relevant Design/SRM Team(s).
  • Ensure Projects quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas is compliant for assigned projects.
  • Determining inspection frequencies and sampling plans using significant testing and capability studies; Implementation of Statistical Process Control in areas where needed and appropriate, analysis of data obtained.
  • Host Customer meetings and be available for regulatory audits at site and follow through with any corrective actions.
  • Support customer complaint analysis and post market surveillance activities

Job Requirements:

  • Degree in Quality, Engineering or equivalent.
  • At least five years’ experience in Quality environment, preferably in Healthcare/Medical Device industry.
  • Ability to work under strict time constraints and meet deadlines in a timely manner.
  • Proven ability to work independently and under own initiative.
  • Strong interpersonal and influencing skills.
  • Ability to work as part of a team and meet targets/goals efficiently.
  • PC skills including standard office packages as well as ability to understand and learn customized computer software programs.
  • Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.

For a confidential discussion on this role please contact Christopher O’Toole  on 091-706713 or email christopher.otoole@collinsmcnicholas.ie

For further information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie

 

 


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Christopher O'Toole

Contact Consultant

  • Christopher O'Toole
  • Recruitment Consultant
  • 091 706713
  • Connect with Christopher

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