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- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Quality lead on cross functional Value Improvement, Product Enhancement or New Product Introduction projects responsible for Test Method Validations, FMEA development, Validation review.
- Use problem solving expertise to drive root cause identification for process and product issues
- Approval of change requests for product, process and quality system changes.
- Identification & utilization of key quality metrics in areas of responsibility to identify improvement opportunities.
- 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).
- Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- Transfer and implement product and processes from development or from another manufacturing facility.
- Ideally will possess Bachelor of Science Degree in Engineering/Technology.
- 3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 desirable.
- Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
- Experience/training in problem solving and process improvement methodologies.
For further Information on this role, please contact John on 021 4911065 or email firstname.lastname@example.org
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