GDP, GCP, GLP, and GVP audits, both remote and on-site. Oversee third-party audits, ensuring findings are risk assessed, reported, and closed with appropriate CAPAs; follow up on CAPA completion. Maintain and assess approved supplier and vendor lists, including criticality ratings and compliance status. Ensure all qualification and requalification activities align with EU, UK, and FDA GxP expectations andMore ❯
system at the sites via adherence to applicable policies and procedures.Complete Quality and Health, Safety and Environmental (HSE) System related actions in a timely manner according to procedures e.g. CAPA, NCR. Adhere to Health, Safety and Environmental (HSE) policies and procedures Qualifications Education: Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related technical More ❯
Birkenhead, Merseyside, North West, United Kingdom
Russell Taylor Group Ltd
control within production What We're Looking For: Strong background in Quality Assurance, ideally in a manufacturing setting Previous team leadership or people management experience is essential Familiarity with CAPA, audits, and regulatory requirements (ISO, GMP etc.) Strong communication and problem-solving skills Working knowledge of QC processes (desirable) What's on Offer: Competitive salary + bonus 25 days holiday 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 correctiveandpreventiveaction 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 ❯
team ? Exceptional benefits and career development ?? Key Responsibilities: Accreditation & Compliance Maintain ISO9001, ISO13485, ISO18001, ISO14001, and ISO45001 standards Conduct internal and external audits Ensure REACH and ROHS compliance Manage CAPAand document control systems Quality Control Improve manufacturing quality controls to reduce defects and costs Manage supplier performance and customer returns Implement corrective actions to enhance customer satisfaction Customer Support More ❯
team ? Exceptional benefits and career development ?? Key Responsibilities: Accreditation & Compliance Maintain ISO9001, ISO13485, ISO18001, ISO14001, and ISO45001 standards Conduct internal and external audits Ensure REACH and ROHS compliance Manage CAPAand document control systems Quality Control Improve manufacturing quality controls to reduce defects and costs Manage supplier performance and customer returns Implement corrective actions to enhance customer satisfaction Customer Support 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 ❯
Leighton Buzzard, Bedfordshire, South East, United Kingdom
1TECH STAFFING LIMITED
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 ❯
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 andCAPA 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 ❯
/efficiency and maximizing customer satisfaction with the overall goal to increase our overall efficiency and reduce our cost to provide service. You will be a key member of CAPA review board and oversee the execution/follow-up of current CAPAs assigned to Service. Responsibilities Technical Leadership & Escalation Management Lead resolution of complex technical issues escalated from global service More ❯
Collaborate with Product Development, Manufacturing, and Service teams to provide technical guidance and ensure that corrective actions are implemented effectively. Problem Resolution : Develop and implement correctiveandpreventive actions (CAPA) for identified quality issues. Follow up to ensure that solutions are sustained over time. Quality Documentation : Maintain detailed documentation on issues, resolutions, and changes made to processes or products. Ensure More ❯
conjunction with operating staff. Maintain the quality management system via controlling documentation and records. Monitor the organisation's quality performance by gathering relevant data. Monitor and progress of correctiveandpreventiveaction activities, complaint handling and the handling of nonconforming product and provide support and assistance as required. Review existing policies, make suggestions for changes and improvements and their effective 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 ❯
teams. System and Software Support: Oversee support for customer issues, investigations, defect resolution, and lifecycle management. Process and Documentation: Contribute to software process controls, design documentation, risk management, andCAPA activities, understanding QMS requirements. Engineering Excellence: Apply rigorous engineering practices, focusing on design reviews, decision-making, problem-solving, verification, risk management, and safety. Regulatory Compliance: Ensure adherence to standards like More ❯
Cambridge, Cambridgeshire, United Kingdom Hybrid / WFH Options
Nuclera
devices such as networked laboratory instruments, IoT devices, or embedded systems Familiarity with non-functional testing areas, including performance, stress, and scalability testing Exposure to quality methodologies such as CAPA (CorrectiveandPreventive Actions), 8D Problem Solving, or Six Sigma Ability to contribute to test strategy documentation and quality-related process improvements across cross-functional teams Familiarity with software security More ❯
Oversee 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, andCAPA processes, solid understanding of the QMS Engineering Excellence : Apply rigorous, science-based engineering practices to design reviews, decision-making, problem solving and verification testing, with a strong focus on risk More ❯
ment by utilising the Supplier Performance Tool - Reporting the Performance of the Suppliers to the key stakeholder via the Supplier Performance Tool. Be responsible for the deployment of correctiveandpreventiveaction plans which address process, product, or component alerts from industrial operations, customer line fit manufactures, or field support. Review of threats to supply and ensuring appropriate risk mitigation More ❯
High Wycombe, Buckinghamshire, England, United Kingdom
Cpl Life Sciences
research into new materials and capabilities for future product developments Diagnose product complaints received, identifying the root causes of any problems. Systematically capture all analysis and resultant actions in CAPA system. Write and manage all inputs and analyses required for the Company’s technical files, working closely with the Company’s regulatory consultant. Work with Manufacturing to identify and evaluate More ❯
research into new materials and capabilities for future product developments Diagnose product complaints received, identifying the root causes of any problems. Systematically capture all analysis and resultant actions in CAPA system. Write and manage all inputs and analyses required for the Company's technical files, working closely with the Company's regulatory consultant. Work with Manufacturing to identify and evaluate More ❯
regulatory compliance and risk management. Lead the QMS team, focusing on investigation simplification, robust root cause analysis, and effective CAPAs. Deliver training on investigation techniques, root cause analysis, andCAPA effectiveness. Generate and maintain the site Risk Register and ensure visibility of key risks across stakeholders. Drive continuous Quality Improvement across all UK sites. Lead Quality Improvement initiatives and the … generation of key quality metrics. Facilitate and lead forums such as the Quality Review Board, CAPA team, change control team, and participate in the Quality Committee. Ensure compliance with current regulatory requirements (e.g., MHRA, HTA, FDA). Support and deputise for the Head of Quality when required. Regularly report on QMS performance and risk-based deficiencies. Ensure quality systems are More ❯
and release of IMP to clinical studies on clients' behalf. To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc. Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the … and release of IMP to clinical studies on clients' behalf. To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc. Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the More ❯
Manager and other Subject Matter Experts (SMEs) within the team. Update electrical models in EOM (Amtech) following system modifications. Support root cause analysis (RCA) andcorrectiveandpreventiveaction (CAPA) processes. Attend training sessions and actively engage in personal and professional development. Experience Minimum 5 years of experience in building services. Experience with HV switching, power management/SCADA systems More ❯
Manchester, Lancashire, United Kingdom Hybrid / WFH Options
QIAGEN Gruppe
in manufacturing/assembly/testing/service related tasks with aptitude for metrology and mechatronics; preferably working in interdisciplinary and international teams. - Knowledge of quality methods such as CAPA, cGMP, FMEA, ISO would be beneficial. - Experience with product development and/or life cycle management in a regulated environment (Design Controls according to European and U.S./FDA guidelines … in manufacturing/assembly/testing/service related tasks with aptitude for metrology and mechatronics; preferably working in interdisciplinary and international teams. - Knowledge of quality methods such as CAPA, cGMP, FMEA, ISO would be beneficial. - Experience with product development and/or life cycle management in a regulated environment (Design Controls according to European and U.S./FDA guidelines More ❯