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Quality Technician Cork
I have an exciting opportunity available with a leading medical device company based in Cork. This role is perfect for someone who already has 2 to 3 years' experience in a highly regulated industry as a QA. My client are currently expanding so it is a very exciting time to join the company!
- 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).
- Minimum qualification: Level 7 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 further information on this Quality Technician role in Cork please contact Emma Ward on 091730022 / firstname.lastname@example.org
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