1 to 25 of 71 CAPA Jobs in the UK

regulations, with good understanding of EU GMP requirements and clinical trial manufacturing expectations. In-depth understanding of Quality Management Systems, including deviation investigations, CAPA management, change control and risk management processes. Strong experience reviewing manufacturing and quality documentation, including batch records, specifications, protocols and reports. Demonstrated ability to lead ...

Investigation Ensure accurate and reliable data capture, storage, analysis, and reporting. Lead failure investigations and root cause analysis activities. Drive corrective and preventive actions (CAPA) arising from testing activities. FMEA/FMECA Fault Tree Analysis Fishbone Analysis 5 Whys Statistical analysis techniques Present technical findings, risk assessments, and recommendations ...

Cause Investigation Ensure accurate and reliable data capture, storage, analysis, andreporting. Lead failure investigations and root cause analysis activities. Drive corrective and preventive actions (CAPA) arising from testingactivities. FMEA/FMECA Fault Tree Analysis Fishbone Analysis 5 Whys Statistical analysis techniques Present technical findings, risk assessments, and recommendations tosenior leadership. ...

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 ...

requirements. Lead supplier audits, assessments and qualification activities for software vendors and service providers. Quality Improvement & Auditing Lead and support Corrective and Preventive Actions (CAPA), quality investigations and complaint handling activities. Conduct internal audits of Quality System processes to verify compliance with regulatory requirements and internal procedures. Support external regulatory ...

electronic circuits. Solid knowledge of analog circuit fundamentals, amplifiers, bias circuits, current sources, and signal integrity principles. Demonstrated experience with: ISO9001 Quality Management Systems CAPA processes NCMR management Statistical Process Control (SPC) Failure Mode and Effects Analysis (FMEA) Control Plans 8D problem-solving methodologies Statistical data analysis Experience working directly ...

Technology (SMT) assembly workflows, applying statistical process control (SPC) to track yield rates. Lead root-cause analysis (RCA) and implement Corrective and Preventive Actions (CAPA) for soldering defects, delamination, and component misalignments. Oversee inspections such as Automated Optical Inspection (AOI), X-ray testing, and First Article Inspection (FAI). Ensure ...

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 ...

technology-based environment. Knowledge of quality management systems, supplier development, and continuous improvement methodologies. Experience with root cause analysis, corrective and preventive actions (CAPA), and supplier performance management. Ability to work collaboratively with suppliers, EMS partners, and cross-functional teams to drive quality improvements and operational excellence. Experience working with ...

and clinical documentation, oversees material release (drug substance/product), and leads inspection readiness for regulatory authorities. Third-Party & Vendor Oversight: Manages qualifications, audits, CAPA reviews, and Quality Agreements for external partners including CMOs, CROs, and TPOs. Quality Excellence & Continuous Improvement: Champions global R&D Quality Plans, self-inspections, quality ...

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 ...

performance monitoring and corrective actions Ensure objective evidence is generated and retained to demonstrate conformity to contractual and regulatory requirements Lead nonconformance management and CAPA processes, ensuring root cause analysis and effective closure Support design reviews, verification and validation activities, ensuring outputs meet requirements and acceptance criteria Contribute to performance ...

strategies. Safety and Compliance Promote safe working practices and ensure compliance with Health & Safety, GMP, and company standards. Support audits, inspections, risk assessments, and CAPA activities. Minimum Requirements Qualifications and Experience HNC Level 3 (or equivalent) in a relevant engineering discipline. English, Maths to GCSE Grade 4 or higher Proficiency ...

control of non-conforming parts and associated RCCA. Identifying and diagnosing workmanship problems in Production processes using 5Why’s or similar method and leading CAPA activities. Control of counterfeit components prevention and detection Qualifications, Skills and Attributes Core Requirements Ability to interpret technical drawings, engineering specifications and standards ...

incidents, adverse events, and product quality issues. Experience applying risk management principles in accordance with ISO 14971 or equivalent risk management frameworks. Experience with CAPA processes, root cause analysis methodologies, and effectiveness verification activities. Working knowledge of UK MDR, EU MDR/IVDR, FDA 21 CFR Part 820/QMSR ...

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 ...

support, including issue resolution, system changes, and service optimization. Manage IT requests via the ticketing system and ensure timely responses. Facilitate deviation and CAPA management, ensuring regulatory compliance and continuous improvement. Author and update validation documentation, IT data processes, and other compliance‐related materials. Support audits and inspections related ...

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 ...

and system parameters. Support batch start-up, line clearance, execution and post-batch review activities. Investigate deviations, alarms, reject trends and equipment issues, supporting CAPA activities. Assist with installation, commissioning, qualification and validation activities, including IQ/OQ/PQ. Ensure compliance with GMP, GxP and ALCOA+ data integrity requirements. ...

Product Ownership/Business Analysis/Systems Delivery (typically 7+ years) within regulated environments. Knowledge of PLM, QMS, and Regulatory processes (change control, deviations, CAPA, audits, complaints, submissions/registrations, regulatory documentation). Working understanding of GxP, 21 CFR Part 11, EU Annex 11, data integrity and audit trails. Confident ...

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 ...

running of the QA department and the oversight of the Quality Management System. Manage investigations, including root cause, product impact and CAPA Handle customer complaints and customer regulatory questions Take part in the internal audit programme and support regulatory inspections Approve suppliers and starting materials using a risk-based approach ...

firmware introduction and development would be desirable. Experience of leading problem-solving teams using industry standard tools such as 8D, Ishikawa, 5 why, and CAPA is essential. Skills, Special Competencies IT Literate – Microsoft packages, SAP experience preferred but not essential. Must be self- motivated with the ability to work without ...

Understanding of asset management and reliability principles. Experience supporting CMMS implementations, upgrades, or data migrations. Familiarity with quality systems including change control, deviations, and CAPA processes. Experience supporting continuous improvement initiatives. What we offer in return Eisai offers a competitive salary and excellent wider benefits package that includes, Electric charging ...

and fixtures. -Support FAT/SAT activities and production readiness. Continuous Improvement & Quality -Drive Lean, Six Sigma, SPC and root cause analysis activities. -Support CAPA, non-conformance investigations and process compliance. -Deliver improvements in productivity, quality, cost and delivery. Data Analysis & Reporting Analyse manufacturing data (OEE, yield, scrap, rework) using ...