This is an urgent requirement for a quality/validation engineer to create inspections and auditing plans for validation projects.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Review and analyse the effectiveness of improvement tools and programs.
Conducting benchmarking to develop more effective methods for improving quality
Supporting the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
Review current product and processes in accordance with compliance to standards such as the QSRs, ISO 13485, etc.
Champions 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.
Conducting periodic line audits to assess production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Partnering with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation ofcorrection of design failures and challenges.
Supporting new product introduction as part of design transfer.
Supporting activities related to the Material Review Board.
Conducting investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
Analysing effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Approve IQ, OQ, PQ, TMV or Software Validation
Partnering with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation, correction of process failures when needed.
Development, interpretation and implementation of appropriate processes for monitoring and control methods consistent with the level of process/product risk.
Collecting data and execution and conducting various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Development, interpretation and implementation of standard and non-standard sampling plans
Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
Document, justify, review or analyse 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
Assessing 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
Ensuring effective quality strategies are created for the validation of test methods, process and design.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.