A Quality Engineer is required by CareerWise Recruitment for our Co. Cork based medical device client . Please contact Diarmuid Buckley on 021 4355432 for more information.
Role of this position
- Primary objective is to ensure customer satisfaction by monitoring, controlling and improving all related customer processes.
- Principal customer interface for Quality metrics and improvement initiatives. Identifies, plans, and organizes regulatory affairs for ensuring compliance with the FDA’s Quality System Regulations, ISO 9000, ISO 13485:2003, JPAL as well as all international standards relevant to customer products manufacture.
- Management of closed loop customer complaints and improvement processes.
- Generation and Review and review of Quality Metrics System.
- Overall responsibility for DMR/DHR and Technical Files.
- Data collection, analyzing and reporting.
- Pareto and trend analysis.
- Initiate and drive Continuous Improvement programs.
- NPI Approval including First Article Inspections and Reporting.
- CAPA, NCM and RMA analysis and Improvement.
- QSR Validation protocols and report (IQ, OQ & PQ).
- Conducting Audits to ensure conformance and effectiveness of the Quality System.
- Degree in a Science or Engineering Field
- At least 2-3 years Quality Assurance / Regulatory affairs experience. In a similar Quality Engineering role in the electronics manufacturing industry.
- 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.
For further information please contact Diarmuid Buckley on 00353 21 4355432 for more information.
CareerWise Recruitment (In Search of Excellence)