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Creganna Medical

Quality Engineer

Creganna Medical

  • Galway / Galway city
  • Not disclosed
  • Temporary full-time
  • Updated 27/03/2013
  • Nicola Walsh
this job is expired
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Description

The Quality Engineer will provide quality support to our design team  Major Accountabilities:  Ensure compliance to the quality management system

 

The Quality Engineer will provide quality support to our design team 

Major Accountabilities: 

  • Ensure compliance to the quality management system in all activities
  • Participate in the product development and realization processes to ensure quality is built into all products early in their life cycle.
  • Work with suppliers and customers on the resolution of product quality issues and quality improvement programs
  • Be responsible for site to site line transfers
  • Have experience in process validations and Implementation of effective process controls.
  • Completion of retrospective validation, prospective validation or revalidation of products/processes/tooling or methods as necessary.
  • Quality engineering support to assigned design groups departments ensuring product manufactured conforms to quality standards and specifications, GMP's of all medical device regulatory agencies (eg. FDA, ISO and MDD).
  • Quality representative on relevant Design Team(s).
  • Review and assessment of all quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas.
  • 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.
  • Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective actions to improve product quality and output.
  • Review and writing of document change orders to evaluate each change for quality related issues, initial product release documentation review.
Requirements:

  • Degree in Quality, Engineering or equivalent.
  • At least three 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
NOTE: We do not require agency assistance with this role

 

Ref: 812229
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Creganna Medical

Creganna Medical

 

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