as the Plexus lead to support external customer audits and internal audit activities. Support recertification and surveillance Quality Management System (QMS) audits. Lead product-related CorrectiveandPreventiveAction (CAPA) discussion and closure. Key Job Accountabilities: Serve as the primary customer contact for quality-related issues, including specification inquiries and audits. Lead response and actions associated with customer quality concerns … Process and/or Product Engineer and other Subject Matter Experts (SMEs) to address customer quality concerns. Lead creation of customer defined quality reports. Lead CorrectiveandPreventiveAction (CAPA) development in response to customer request. Provide feedback and documentation to the customer as required. Provide technical training, leadership, guidance and direction to regional and site management and stakeholders. Ensure … identify opportunities to reduce scrap, rework and Clinical Risk Group (CRG)s. Collaborate with the Process and/or Product Engineer to implement improvements. Lead CorrectiveandPreventiveAction (CAPA) development for repeat or systemic issues as well as ensuring implementation. Provide support and leadership in order to effectively design, develop, monitor, maintain, and continuously improve the quality management system More ❯
inventory control. Directly lead the Quality function, including quality engineers, inspectors, and technicians. Ensure full compliance with industry standards and customer-specific requirements. Oversee internal and external audits, correctiveandpreventiveaction programs, and quality training initiatives. Drive the implementation of a Quality Management System (QMS) that supports operational excellence and customer satisfaction. Champion the use of Lean Manufacturing, Six 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 ❯
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 ❯
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 ❯
Barnard Castle, County Durham, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
planning, executing, and documenting GMP audits, managing supplier action plans, and supporting change controls. Responsibilities Perform GMP and Quality System assessments of suppliers and recommend approval statuses. Agree on CAPA plans and ensure their timely completion. Communicate assessment outcomes effectively to stakeholders. Maintain supplier data in management systems and support change controls. Identify risks, escalate high-risk issues, and support 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 ❯
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 ❯
Hereford, Herefordshire, West Midlands, United Kingdom
CURE TALENT LIMITED
continually improve the Quality Management System in compliance with ISO 13485, FDA QSR, EU MDR and other applicable standards. Oversee internal and external audits, including hosting regulatory inspections. Manage CAPA, NCR, and root cause analysis processes, ensuring timely and effective resolution. Ensure effective document control, review and approve quality-related documentation. Support product development projects to ensure quality and regulatory 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 ❯
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 ❯
Solihull, West Midlands, England, United Kingdom Hybrid / WFH Options
Office Angels
Are you capa ble of delivering first class customer service? Do you want to be part of a team that acknowledges your hard work and wants you to succeed Have you answered yes to the above? This could be the next step that you have been waiting for so keep reading... JOB TITLE: Punjabi Speaking Customer Service Advisor LOCATION : Solihull More ❯
Solihull, West Midlands, England, United Kingdom Hybrid / WFH Options
Office Angels
Are you capa ble of delivering first class customer service? Do you want to be part of a team that acknowledges your hard work and wants you to succeed Have you answered yes to the above? This could be the next step that you have been waiting for so keep reading... JOB TITLE: Russian Speaking Customer Service Advisor LOCATION : Solihull More ❯
Solihull, West Midlands, England, United Kingdom Hybrid / WFH Options
Office Angels
Are you capa ble of delivering first class customer service? Do you want to be part of a team that acknowledges your hard work and wants you to succeed Have you answered yes to the above? This could be the next step that you have been waiting for so keep reading... JOB TITLE: Portuguese Speaking Customer Service Advisor LOCATION : Solihull More ❯
Birkenhead, Merseyside, North West, United Kingdom
Total Staff Services
to senior management on quality metrics and system performance. Assist in developing various teams across site on quality standards and best practice Support the understanding across the site of CAPA's, their importance, and ensure KPI's for CAPA's are met. Develop and foster excellent working relationships with our customer's Quality Assurance Manager's Stay updated on relevant 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 ❯
Ware, Hertfordshire, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
on supplier GMP approval status (including proposals for continued use of suppliers with marginal compliance) and documenting assessments/audits in relevant systems. Agreeing appropriate correctiveandpreventiveaction (CAPA) plans with suppliers … and following up on the completion of CAPAs within agreed timelines. Effective communication of assessment outcomes to internal and external stakeholders, ensuring audit-related documentation is effectively communicated and that CAPA-related documents are reviewed and responded to within targeted timelines. Maintenance of "auditee" (supplier) profiles in data systems, ensuring that supplier data associated with the supplier assessment and user 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 ❯