1 to 25 of 36 CAPA Jobs in the UK

or similar systems). Skills: Strong understanding of quality management systems, particularly ISO 9001, IATF 16949, or equivalent standards. Experience in conducting internal audits, managing non-conformities, and applying CAPA principles. Familiarity with continuous improvement methodologies such as Six Sigma, Lean, or Kaizen. Strong problem-solving and analytical skills, with the ability to assess processes and drive change. MS Office More ❯

within the organisation Oversee the change control process ensuring that it maintains the requirement of ISO 13485; and all other relevant regulatory requirements within the quality system. Oversee the CAPA and internal/external audit processes Prepare quality documentation as required for other worldwide territories eg FDA, TGA etc to support submission. Manage customer tracking as it relates to quality More ❯

the R&D team and senior management. Maintain current knowledge of federal, state, and international regulations and guidance documents, as applicable (QSR, cGMP, ISO, ICH, etc.). Support NCMR, CAPA, Complaint, and Internal Audit investigations as needed. Thoroughly document all issues related to quality control, QSR, cGMP, ICH, and ISO compliance. Support company goals and objectives, policies, and procedures. Requirements More ❯

Manager, you'll take ownership of the Quality Management System (QMS), ensuring full compliance with ISO 13485 and associated regulatory standards. You'll lead internal and external audits, drive CAPA implementation, manage documentation and validation processes, and promote continuous improvement across quality systems. This is a full-time, office-based role (minimum 3 days per week on site) with occasional … international travel. What you'll need to succeed Hands-on experience managing ISO 13485:2016 compliant QMS Strong knowledge of risk management (ISO 14971), GCLP, CAPA, and validation (IQ/OQ/PQ) Background in biotech, biomedical science, immunology, or similar Solid understanding of regulatory submissions and eQMS platforms Confident communicator and proactive team player with excellent problem-solving skills More ❯

customer complaints, supplier issues, internal incidents, holds and derogations. Providing data for KPI where required Ensuring compliance to spec driving continuous improvement through root cause analysis and troubleshooting activities (CAPA) Driving cross functional communication with operations team, engineering and NPD (including other teams as relevant) to provide timely and correct information in line with job role Completing and taking part More ❯

trials. To liaise with other centres for clinical research to ensure common standards of practice. Quality and Risk Management: Coordinate the management of QMS documentation (Change Controls, Deviations, Investigations, CAPA, Risk Assessments) and ensure proper recording and investigation of errors, incidents, and complaints. Co-ordinate the management & updating of SOPs, Logs and controlled documents. Conduct routine risk assessments on outsourced More ❯

meetings and the management of the meetings outputs. Supporting Regulatory, ISO and Client audits, and conducting Supplier audits, internal audits, and self inspections, including the preparation of responses and CAPA plans. Key Skills/Experience/Requirements: Strong organisational and communication skills, with excellent attention to detail. Ability to show initiative and be proactive, working well under pressure and to More ❯

primary contact with regard to Quality performance Administer the Fault Analysis Reporting process and ensure that the reports are distributed to management and monitor the completion of the corrective and preventive action of each entry. Manage the internal and external audit process and assist with audits where appropriate and/or necessary. To ensure that the Quality Systems are harmonised More ❯

Responsibilities Develop, implement, and maintain QA processes compliant with ISO 9001:2015 and ISO 14001 Manage document control, quality records, and internal audits Conduct root cause analysis and implement CAPA Liaise with auditors, certification bodies, and suppliers Ensure compliance with IPC-A-600, IPC-A-610, and UL regulations Monitor KPIs and generate quality reports Support product transition from R … in electronics or materials Proven experience with ISO 9001:2015 and ISO 14001 systems Familiarity with IPC standards and UL regulations Analytical skills, experience in root cause analysis and CAPA Audit preparation and leadership experience Strong communication and report-writing skills Proficient in MS Office and quality software Ability to calculate and produce LCAs Desirable: Certified ISO 9001:2015 internal More ❯

adaptations. · Oversee complaint handling and post-market surveillance, including root cause analysis, hazard assessment, and escalation. Core QA Responsibilities · Own and manage the following processes: Document Control, Change Control, CAPA, Supplier Evaluation and Monitoring, Management Review and Training. · Support and guide process owners in regulatory interpretation, risk-based decision making, and change implementation. · Lead and coordinate internal audits to ensure … as Mirada’s Management Representative (MR). QA Subject Matter Expert (SME) Responsibilities · Act as SME for Process Validation Purchasing and Supplier Management Management Responsibility Document Control, Change Control, CAPA, and Complaints Information Security and Customer Support Processes Information Security Responsibilities · Maintain and implement ISMS policies and procedures as Information Security Officer with the support of Technical Information Security Officer More ❯

tasks, and mentor junior team members. What you'll need: Experience in a Quality Assurance function in pharmaceutical or food manufacturing Experience with QA tools such as RCA and CAPA Auditing experience Ready to join a company offering the chance of genuine progression? Click apply, and let's discuss your future. By clicking Apply you accept our privacy policy (see More ❯

responsibility for ensuring site compliance with MHRA and GMP guidelines. The role involves leading continuous improvement and change management initiatives, as well as acting as the site lead on CAPA projects. Job Details: Pay: £50,000 per annum Hours of Work: Monday to Friday, 8am - 4.30pm Duration: Permanent Essential Skills & Experience: Previously held a Senior Technical Manager, Manufacturing Manager or More ❯

to maintain regulatory compliance Provide QA/RA expertise throughout product development and change control processes Guide risk management and post-market surveillance activities Conduct root cause analyses for CAPA investigations Review SOPs, software development documents, and regulatory submissions Deliver training to ensure quality and regulatory understanding across the business Perform internal and supplier audits and support external inspections Validate More ❯

to completion. Prepare monthly metrics for their area of expertise/responsibility. Analyze process data and trends and drives optimization/improvement. Represent QA organization in specific processes (e.g. CAPA, Order fulfillment, Manufacturing, Deviation management etc.) Support others in the QA organization and other functional organizations on technical aspects to drive results. Participate in external audits before regulatory authorities. Promote More ❯

experience. Bachelor's degree in engineering or equivalent scientific/technical discipline. System-based thinking and excellent analytical skills are required. Expert using quality tools such as FMEA, SIPOC, CAPA, 5 Why's, 8D, RCCA, TQM. Expert knowledge of ISO 9001:2015 Quality Management System. Experience with working in a Test-Driven Development environment. Must possess an innate sense of More ❯

and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong More ❯

and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong More ❯

based in Staffordshire: HNC/HND/Bachelors degree in Engineering Relevant quality assurance or engineering certification MUST have come from a production/manufacturing background Proficient in 8D, CAPA, Six Sigma, SPC This is a great opportunity for Quality Assurance Engineer (Manufacturing) that has attention to detail, takes pride in their work and wants to do the best for More ❯

based in Staffordshire: HNC/HND/Bachelors degree in Engineering Relevant quality assurance or engineering certification MUST have come from a production/manufacturing background Proficient in 8D, CAPA, Six Sigma, SPC This is a great opportunity for a Quality Assurance Engineer (Manufacturing) who has attention to detail, takes pride in their work, and wants to do the best More ❯

the analysis and visualisation of a wide range of data sources across the clinical development and post-marketed product lifecycle. This includes critical PDQ data such as Audit, Inspection, CAPA, and Deviation data. You will play a key role in delivering impactful outcomes for the business by: Ensuring the availability of quality data and information by understanding data collection methods More ❯

Assessments to validate readiness for production transfers. 🧾 Non-Conformance & Risk Management Document audit findings, raise non-conformances, and agree on corrective/preventive actions (CAPAs). Follow up on CAPA implementation and effectiveness. Identify risks and improvement opportunities to inform supplier development strategies. Tools & Methodologies Use internal audit platforms and industry standards (e.g., AS/EN 9101, Nadcap). Apply More ❯

related field. 5+ years of QA experience, including test plan creation and execution. Strong analytical skills, attention to detail, and working knowledge of defect-tracking, CI/CD, and CAPA processes. Strong knowledge of SDLC/STLC, Agile/Scrum, risk-based testing, and defect lifecycle. Excellent English communication – written test reports, verbal risk summaries, stakeholder presentations. Would be a More ❯

and maintain product specifications and process procedures, including monitoring approval records (Agility System). Control of contract quality plans and monitor live QP s for daily status. Control of CAPA s, ECR s. Certificate checks and stamped sign off against standards and HT PO text. Control of Sub- Contract deliveries monitoring progress, compliance, and due dates. Maintain and control of More ❯

Provide technical support for customer and product investigations, defect resolution, lifecycle maintenance, and feature enhancements. Process and Documentation: Contribute to software process controls, design documentation, risk management activities, and CAPA processes. Requirements and Architecture: Translate customer and business requirements into robust embedded systems and software architectures aligned with product goals. Technical Analysis: Interpret technical documentation such as circuit diagrams and More ❯

including internal and external sales personnel, Professional Services, Engineering, and Data Center teams to ensure that technical support issues are properly addressed including the use of the NC/CAPA process. Use ticketing system and CRM to track and resolve all open customer issues. Review and execute existing procedures (Work Instructions) to ensure compliance with current practice and Sensitech's More ❯