- Reference: CJ44653
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
Due to continued expansion of our operations, we are seeking applications from a suitably qualified Quality Engineer.
- Supervision of Quality Technicians.
- 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.
- Ensure 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).
- Drive and implement plant wide quality system improvements.
- Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- 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).
- Level 8 qualification required in Science or related discipline
- 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 a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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