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Quality Engineer II- Cork
Our client, a medical device company in Cork are currently looking to recruit a Quality Engineer II for their site.
- Supervision of Quality Technicians and QC Inspectors.
- 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).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Minimum of a 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 necessary.
- Demonstrate strong leadership skills and promote quality at source
- Develop plans and execute on time to these plans
- 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 (Engineering Essentials TM).
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