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 ❯
audits; maintain audit documentation and support auditor development. Ensure full compliance with QMS requirements, including document control, risk-based thinking, and continuous improvement practices. Manage CorrectiveandPreventive Actions (CAPA), support root cause analysis, and ensure timely resolution of quality issues. Lead quality initiatives, capability studies, and data-driven performance reporting. Collaborate with Engineering on new product development, design reviews 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 ❯
bodies and regulatory authorities during external audits and inspections. Oversee the drafting and updating of QMS, ISMS procedures, work instructions and forms; ensure effective document control and distribution. Oversee CAPAand complaint investigations for our medical devices and ensure that activities are initiated, planned, executed and closed within defined timelines. Analyse trends from quality management system data, coordinate internal audits More ❯
to recommend service improvements. Work with ITSM teams to ensure accurate SLA tracking and OLA performance reporting within ServiceNow. Support the definition and implementation of correctiveandpreventive actions (CAPA) based on insights. Develop and manage automated and custom reports from ServiceNow Performance Analytics, ServiceNow Reporting, and other BI platforms (e.g., Power BI) Create real-time dashboards to monitor IT More ❯