Quality Engineer - CAPA Coordinator
Our client, a manufacturing company in Cork are currently looking to recruit a Quality Engineer - CAPA Coordinator for their site.
Objectives of Position:
- Expert in the agile CAPA System (CCN, CAR, SCAR and PAR) and associated Processes.
- Review and help script CAPA in a Regulatory Compliant Manner
- Provide Training and Expertise in the CAPA Process
- Review, Evaluate, Verify and check the effectiveness of CAPA as required
- Provide help and guidance to SME's in the completion of CAPA
- Keep abreast with regulatory requirements and Guidance on CAPA
- Coordinate & Close Out of CAPA and PAR's in timely & efficient manner.
- Generation and Review and review of CAPA Reports, CAPA Analysing, Pareto, Trending and Associated Recommendations for improvements.
- Participating/ Internal Audits to ensure conformance and effectiveness of the Quality System.
- CAPA On Time Closure
- Engineer will specialize in CAPA co-ordination.
- CAPA Reports and Summaries
- Successful & timely close out of CAPA's as per target deadlines.
- Customer Satisfaction Index, (CCN, CSO etc)
- Customer Return % and Cost (RMA)
- Degree in Science or Engineering, or a lesser qualification with sufficient job related experience
- At least 4+ years Quality, Quality Assurance / Regulatory affairs experience in a similar Quality Engineering role in electronics manufacturing or Medical Devices Industries.
- Ideally experience of the CAPA Process in a regulated environment
- Sound understanding and utilization of Problem Solving Techniques
- Proficient in the use of Microsoft Word, Power-point and Excel.
- Good Communications and influencing skills.
- Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
- Ability to write standard operating procedures, training documents, and regulatory responses.
- Experience in working within a Class 3 Medical Device Manufacturing Environment.
- Six sigma Green or Black Belt Certified
- Experience in New Product Introduction Processes
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