Operations Quality Engineer
|Job Title:||Operations Quality Engineer|
|Job Published:||about 2 years ago|
Our client, a medical device company in Galway requires an Ops QE for a permanent role
? Provide quality support to assigned production departments ensuring product manufactured conforms to quality standards and specifications, GMP's of all medical device regulatory agencies (e.g. FDA, ISO and MDD).
? Determining inspection frequencies and sampling plans using significant testing and capability studies; analysis of data obtained.
? Monitor and evaluate quality inspection procedures to ensure consistency, compliance and effectiveness, making recommendations for improvement and/or adjustment where needed to Technical Teams / Management for assigned Production Departments (Component, Sub Assembly & Finished Goods). Where appropriate implement approved changes.
? Review and assessment of all quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas as appropriate.
? Non-conforming product review and disposition; investigation of deviations/returned goods and implementation of appropriate and effective corrective / preventive actions to improve product quality and output.
? Providing guidance, direction to product line Quality Assurance Auditors, Team Leaders / Supervisors on quality aspects of products relating to production departments assigned.
? Review of document change orders to evaluate each change for quality related issues, initial product release documentation review.
? Completion of retrospective validation, prospective validation or revalidation of products / processes / tooling or methods as necessary.
? Quality representative on relevant Technical Team(s).
? Performance of Internal Quality Audits.
? Degree in Quality Engineering or equivalent.
? Two to three years (+) experience in Quality environment, preferably in Healthcare/Medical Device industry in a similar role.
? Knowledge of quality principles as defined in the regulations and the ability to utilize these methods in a manufacturing environment.
? Experience of applying Lean Six Sigma techniques to improve business processes & performance although not required is desirable.
? PC skills including standard offices packages as well as ability to understand and learn customised computer software programs.
For further information on this Quality Assurance Engineer role in Galway please contact Cliona O?Malley on 091730022 / cliona @hero.ie
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