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Quality Engineer – CAPA Coordinator

Job Title: Quality Engineer – CAPA Coordinator
Contract Type: Permanent
Location: Cork
Industry:
REF: 90179
Job Published: 9 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

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
Responsibilities:
  • 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.
Measurements:
  • CAPA On Time Closure
Additional Information:
  • 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)
Personnel Specifications
Essential:
  • 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.
Desirable:
  • Experience in working within a Class 3 Medical Device Manufacturing Environment.
  • Six sigma Green or Black Belt Certified
  • Experience in New Product Introduction Processes
For further information on this Quality Engineer - CAPA Coordinator role in Cork please contact Bimi Felix on 0868395533 / bimi@hero.ie
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