Quality Engineer Job Cork
QE job in Cork available now with our client. This Quality Engineer job is a permanent position in Munster. For this Quality Engineer Cork job the successful candidate will be driving and implementing quality system improvements
Key Responsibilities of the Quality Engineer:
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
- Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
- nsure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (E.g. Use of DOE studies, FMEA's).
- Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
- Minimum qualification: BSC/BEng degree.
- Minimum of 2/3 years' experience in a QA role.
- Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
For further information on this Quality Engineer Job in Cork or if you are interested in other Quality Engineering roles elsewhere, please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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