Our client is currently looking or an experienced quality engineer to support a project related to compliance of all manufacturing operation activities in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production.
• Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
• Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• Ensure the development of a comprehensive risk management plan for the product and process
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• 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
• Assists in the development of manufacturing and inspection procedures.
• Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
* Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree • experience in quality engineering • Experience with ISO 9000, ISO 13485 and GMP
• Experience in Design and Process validation
• Quality Tools Knowledge
• Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
• knowledge and skills in PLM system, Agile PLM, SAP, Windchill,
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.