8 of 8 Remote/Hybrid CAPA Jobs in England

experience in Complaints Management for Medical Device Strong understanding of FDA, EU MDR/IVDR requirements and Reporting Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both ...

manufacturing industry regulations (e.g. ISO 9001, GAMP 5, ISO 27001, 21 CFR Part 11) and data integrity guidelines. Lead root cause analysis (RCA) and CAPA for IT system outages, data synchronization failures, or automated line disruptions. Collaborate with OT, Automation, and Systems Engineering teams to validate software updates, digital twin ...

delivery performance. Conduct quality reviews of project outputs, technical documentation, processes, and deliverables. Monitor trends, identify recurring issues, and drive improvement initiatives. Facilitate corrective and preventive action programmes where performance falls below expected standards. Produce quality reports and recommendations for senior management. Supplier & Partner Management Assess supplier quality performance and ...

and manufacturing software across our automated manufacturing facilities. You will validate shop-floor systems (MES, ERP, SCADA) and IoT devices, lead RCA and CAPA for outages, and design automated and manual test plans. Work is hybrid with flexible hours, strong career progression, and a culture focused on quality and continuous ...

with relevant quality standards and customer requirements. Leading internal and external audits and supporting corrective actions. Driving root cause analysis, corrective and preventive actions (CAPA). Monitoring quality performance, trends and key quality metrics. Supporting non-conformance, defect and customer complaint processes. Working with manufacturing and engineering teams to improve … Quality Management Systems, ideally ISO 9001 and/or other relevant industry standards. Internal and external audits. Root cause analysis and structured problem solving. CAPA, non-conformance and corrective action processes. Continuous improvement methodologies. Quality assurance and process control within an electronic manufacturing environment. Supplier quality and customer quality requirements. ...

activities in line with ISO 14971 , including hazard analysis, risk evaluation and mitigation strategies. Supporting post‐market surveillance, vigilance and complaints investigations , ensuring robust CAPA and documentation. Working as part of, or leading, cross‐functional project teams , managing quality deliverables, tracking actions and supporting timely decision‐making. Qualifications … environments. A well‐developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering . Experience with supplier quality, audits, CAPA and document control . Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders. We know the skill-gap and ...

effective decision-making as the organisation scales. Working cross-functionally, the successful candidate will manage and improve quality activities including document control, SOPs, nonconformances, CAPA, change control and internal audits. They will also review existing processes, identify opportunities for improvement, maintain quality records and contribute to technical documentation. This … optimisation of workflows and quality processes. Review existing processes to identify gaps, inefficiencies and practical opportunities for improvement. Govern quality activities including nonconformances, CAPA, change control, internal audits and quality metrics. Generate, review and revise SOPs, technical documentation and associated quality records. Work cross-functionally to support compliance across software ...

both technical support teams and clinical teams. Participates in audit and regulatory inspection preparation activities and assist in the development and delivery of CAPA to time and quality, when applicable. Participates in inspection/audit preparation activities and assist in the development and execution of CAPA plans, when applicable. Continuously ...