Description
* Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports.* Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. * 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.* Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software. * Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.