14 of 14 CAPA Jobs in London

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 ...

risk management activities, including SFMEA, hazard analysis, risk mitigation, and verification. Support verification and validation planning, execution, documentation, defect investigations, root cause analysis, and CAPA activities. Contribute to software configuration management, change control, release readiness, and documentation consistency. Support internal/external audits and regulatory readiness while monitoring software quality ...

building and managing high-performing Quality teams. Expert command of the core Quality toolkit: QMS, ISO 13485, design controls, ISO 14971 risk management, CAPA, validation, and supplier quality. Experience hosting and leading audits, including annual certification audits. Preferred audit certifications (ASQ CQE/CQA/CMQ-OE, RAC, Lead Auditor ...

including EU MDR trending obligations. Partner with cross-functional stakeholders to drive continuous improvement, maintain product quality standards, and support regulatory inspections, audits, and CAPA activities. Skills, Experience & Qualifications Proven experience analysing complex datasets and translating findings into actionable business and quality insights. Prior experience working within a Medical Devices ...

stakeholder communications, and execution controls protect data center availability. The role leads incident response and post-incident reviews, directs root cause analysis and corrective and preventive action plans, validates commissioning and design deliverables, oversees site assessments and build activities, and establishes consistent operational policies and procedures. The Senior Manager holds ...

MHRA Software and AI as a Medical Device programme, MDCG guidance, FDA guidance, IMDRF) and assess impact on products and the QMS. Support CAPA and internal audit follow-ups where regulatory root causes are identified. What We’re Looking For 3 to 6 years' Regulatory Affairs experience in Medical Devices ...

software release pipelines and hardware manufacturing runs, facilitating strict "Go/No-Go" readiness reviews prior to customer delivery. Continuous Improvement & Root Cause Analysis (CAPA): Implement robust Corrective and Preventive Action (CAPA) processes, analyzing field performance data, warranty claims, and customer defect tickets to drive iterative product and process enhancements. … quality control gates. Proven process excellence capabilities , with deep familiarity or certification in Six Sigma, Lean, or ISO quality methodologies, using defect analytics and CAPA processes to eliminate repeat failure modes and achieve strict SLA metrics (e.g., 99.99%+ uptime, MTBF targets). This position is based in London and ...

requires regular travel across Europe/Nordics, with focus on high-density AI cooling and power. You’ll perform design reviews, audits, RCA/CAPA, and coach site engineers to improve reliability and energy efficiency. #J-18808-Ljbffr ...

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 ...

supports remediation efforts to project audit observations Promote GCP compliance by authoring records (e.g., project audit reports) Perform process improvement activities and incident/CAPA investigations Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and … 3+ years in a Clinical QA role in Life Sciences Experience with Quality Management Systems (e.g., documentation and record management, computer system validation, investigations, CAPA programs) Working knowledge of Quality Principles as manifest in ISO 9001 or QSRs, GCP regulations and guidelines Proven technical writing skills Comfortable in a fast ...

continuously improve our QMS in line with ISO 13485, 21 CFR Part 820, and other relevant standards.* Manage core quality processes, including document control, CAPA, nonconformances, complaints, supplier management, and change control.* Plan and conduct internal audits, and support the business through external audits and inspections by certification bodies and … diagnostics, or digital health industry (typically 2–5 years).* Hands-on experience operating within an ISO 13485 certified QMS, including processes such as CAPA, document control, and internal audits.* Some exposure to regulatory affairs, such as contributing to technical documentation, submissions, or regulatory assessments.* Working knowledge ...

stakeholder communications, and execution controls protect data center availability. The role leads incident response and post-incident reviews, directs root cause analysis and corrective and preventive action plans, validates commissioning and design deliverables, oversees site assessments and build activities, and establishes consistent operational policies and procedures. The Senior Manager holds … post-incident review processes by guiding cross‐functional teams through root cause analyses, institutionalizing lessons learned, and driving the development and governance of Corrective and Preventive Action Plans (CAPAs) to mitigate systemic risks and enhance global infrastructure resilience. Partners with key stakeholders and drives collaborations across teams during emergency response ...

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 ...

site, helping diagnose faults and guiding safe recovery of M&E systems. Own Root Cause Analysis (RCA) creation and closure, and drive Corrective and Preventive Actions (CAPA) through to completion. Lead structured problem solving on complex and recurring faults, using trend, alarm and maintenance data to resolve underlying causes rather … operational risk of works on live M&E systems. Experience leading or contributing to Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) following M&E system incidents, with a structured approach to problem solving. Confident supporting site teams under pressure during live incidents, and comfortable coaching and training ...