Our client requires a QA Engineer for a permanent role in Cork. The Quality Engineer will utilize tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The QE will utilise principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
- Support quality improvement initiatives and review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champion compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Prepare documentation to support any regulatory submissions as a result of implementation of new technologies / inspection methods.
- Supports activities related to the Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Generate IQ, OQ, PQ, TMV Protocols and Reports
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Education, Experience and Skills:
- Bachelor?s Degree, preferably in Engineering or related technical field. Generally requires 2-4 years related experience working in both an FDA and European regulatory environment is preferred.
- Knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
For further information on this QA Engineer please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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