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Senior Quality Engineer

Job Title: Senior Quality Engineer
Contract Type: Permanent
Location: Galway
REF: 82212
Job Published: 7 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533
Senior Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Engineer for their site. The Senior QE will be responsible for establishing inspection standards, plans, frequencies and test methods and preparing and approving procedures, routing set-up's and shop floor documentation.

Key Responsibilities of the Senior Quality Engineer job
  • Understand the requirements of design control and facilitate design review projects.
  • Preparing/Reviewing Master Validation Plans, FMEA's, Risk management plans
  • 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
  • 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.
  • Support customer complaint analysis and post market surveillance activities
Education, Experience and Skills of the job:
  • Level 8 Honours 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.
For further information on this Senior Quality Engineer role in Galway or other Senior QE jobs please contact Bimi on 086 8395533/

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