1 to 25 of 34 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 ...

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 ...

external), compliance programmes, and writing and maintaining processes and procedures. Quality certifications such as Six Sigma are a plus. Experience leading structured CI (RCA, CAPA, KPI reviews). Experience managing and developing people. Customer advisory and cross-functional partnership: a clear communicator who can translate customer quality requirements into acceptance ...

competing priorities. Excellent written and verbal communication skills Desirable experience: Medical devices and regulated products. ISO 13485 and quality management systems. Six Sigma methodologies. CAPA investigations. Business Central. Electronics fault-finding to component level. #J-18808-Ljbffr ...

competing priorities. • Excellent written and verbal communication skills Desirable experience: • Medical devices and regulated products. • ISO 13485 and quality management systems. • Six Sigma methodologies. • CAPA investigations. • Business Central. • Electronics fault-finding to component level. If this sounds like you and you can commit to a 12 month role, please contact ...

production automation support, focusing on equipment breakdowns, with flexibility in working hours as required Participate in Continuous Improvement activities, including DMAIC, RCA, and CAPA processes and input into deviations as automation SME. Deputising for the site automation lead as required About You This role is suited to a motivated person ...

yield or test failures. Interface with suppliers on component quality, technical issues, using structured root cause analysis (RCA) to drive corrective and preventive actions (CAPA). Leadership & Global Collaboration Demonstrate technical leadership within GE Vernova’s global R&D and engineering structure. Act as a key technical interface between ...

yield or test failures. Interface with suppliers on component quality, technical issues, using structured root cause analysis (RCA) to drive corrective and preventive actions (CAPA). Leadership & Global Collaboration Demonstrate technical leadership within GE Vernova's global R&D and engineering structure. Act as a key technical interface between ...

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 ...

Ensuring compliance with ISO9001 and supporting audits Acting as a customer‑facing quality representative, handling queries and driving resolution Supporting root cause analysis, CAPA, and continuous improvement initiatives Quality Manager - Electronic products - What You’ll Bring Strong experience in electronics manufacturing Proven background in quality engineering at a senior ...

Ensuring compliance with ISO9001 and supporting audits Acting as a customer facing quality representative, handling queries and driving resolution Supporting root cause analysis, CAPA, and continuous improvement initiatives Quality Manager - Electronic products - What You ll Bring Strong experience in electronics manufacturing Proven background in quality engineering at a senior ...

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 ...

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 ...

Management: Timely completion of customer tickets in line with company procedures. Communicate customer feedback, contribute to and drive solutions in line with the company CAPA (Corrective and Preventative Actions) Process and Zero Defects policy. Required Skills and Education: The engineer must be able to communicate clearly and confidently, technical aspects ...

analog circuit design, signal integrity, high-speed amplifiers, bias circuits, and current sources. Extensive experience with quality systems and tools including ISO 9001, CAPA, NCMR, SPC, FMEA, Control Plans, 8D, and statistical analysis. Proven customer and supplier quality experience across wafer fabrication, assembly, testing, and optical module manufacturing. #J ...

analog circuit design, signal integrity, high-speed amplifiers, bias circuits, and current sources. Extensive experience with quality systems and tools including ISO 9001, CAPA, NCMR, SPC, FMEA, Control Plans, 8D, and statistical analysis. Proven customer and supplier quality experience across wafer fabrication, assembly, testing, and optical module manufacturing. #J ...

/PCBA manufacturing knowledge IPC-A-610 and/or J-STD-001 experience AS9100 and/or ISO 9001 experience Root Cause/CAPA/8D/FMEA experience ERP/MRP experience Hands-on measurement, inspection and test equipment knowledge These requirements closely reflect the essential experience identified ...

/PCBA manufacturing knowledge IPC-A-610 and/or J-STD-001 experience AS9100 and/or ISO 9001 experience Root Cause/CAPA/8D/FMEA experience ERP/MRP experience Hands-on measurement, inspection and test equipment knowledge These requirements closely reflect the essential experience identified ...

/PCBA manufacturing knowledge IPC-A-610 and/or J-STD-001 experience AS9100 and/or ISO 9001 experience Root Cause/CAPA/8D/FMEA experience ERP/MRP experience Hands-on measurement, inspection and test equipment knowledge These requirements closely reflect the essential experience identified ...

return rates as volumes grow. Establish and drive quality processes across the NPI lifecycle, including FMEA, root cause analysis, and corrective/preventive action (CAPA) programs. Champion a culture of proactive quality, embedding lessons learned from prior programs into new product designs. Supplier Management Lead supplier sourcing, qualification, and onboarding ...

seeking a Senior Product Quality Engineer for our international semiconductor client. The role drives customer quality improvements across development and manufacturing, leading RMAs, CAPA actions, and ISO 9001 compliant processes. You will guide NCMR handling, supplier quality, and continuous improvement initiatives, including Lean, Six Sigma, and 5S, to ensure product ...