- Reference: GY43157
- Job Type: Contract
- Location: Clare, Galway, Galway city
- Category: Engineering, Technical & Manufacturing
Our client is currently recruiting for a Quality Technician in the Medical Technology Field. This is a 12 month fixed term contract – shift work.
Provide first level Quality Engineering support to production. Role model quality compliance best practices on shift. Be the primary point of contact for any quality excursions and act immediately to control all affected product and resolve the non-conformance. Work with Engineering on new equipment and program releases.
Principal Duties and Responsibilities
- Disposition all non-conforming lots on hold in a timely manner and fully compliant to procedure.
- Assess all product builders in training for certification readiness.
- Analyse all gage calibration failures for impact to product and conduct follow-up activities as necessary to control all affected product.
- Support Engineering through review of program First Article Lay-outs and through qualification of new equipment.
- Conduct test Method Validations on product acceptance activities.
- Analyse and report out on all quality performance metrics and take action to address any adverse trends.
- Support the cleanroom monitoring program and investigate and respond to any out of control events
- Act as the primary Quality point of contact on shift and coach and mentor all production personnel on
- Quality compliance best practices.
- Analyse the impact of unscheduled maintenance on the validated state of any process and ensure that the process has been returned to its validated state prior to release of equipment back to production.
- Support site transformational projects as necessary.
- Lead yellow belt teams to investigate and resolve any quality compliance or performance issues, as needed.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the “essential functions” for purposes of the ADA.
Education/ Experience Requirements
- Advanced knowledge of the following measurement devices: calliper, micrometer, and optical comparator.
- In depth knowledge of Good Manufacturing Practices.
- Familiarity with QSR and FDA requirements.
- Should be familiar with general dimensioning and tolerances (GD &T).
- A knowledge and proficiency in coordinate measuring machine (CMM) operations would be useful
- Familiarity with computer production tracking software or spreadsheet manipulation.
- Diploma in Quality or related field.
- Previous experience in a quality related role desirable.
For a confidential discussion and a more detailed job spec (more information on the role), please contact Claire O’Donnell on 091-706717 or email email@example.com
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