Job Summary Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT's unique and market leading nanopore-based next generation gene-sequencing (NGS) technology. In addition to selling its technologies and products into research use only applications, the firm … the EU IVDR. • Establish strong working relationships across the business to facilitate best practices in the risk management, product development, testing, manufacture and post marketsurveillance of products. • To support (and as required lead) all internal and external audits (customer, regulatory, certification etc.). • Any other reasonable duties … risk management and change management. Experience of team management and leadership of teams >5. Experience and consequent deep understanding of design/development (pre-market) activities, production control (in both "single piece flow" and "batch/volume" production environments), and post-market (lifecycle change management) areas. Experience of More ❯
Aylesbury, Buckinghamshire, South East, United Kingdom
Halian Technology Limited
and includes the following: ? Technical file documentation, to ensure compliance with MDR and FDA; for example biocompatibility reports, clinical evaluations, risk assessments, and post marketsurveillance ? Quality system management, to ensure compliance with MDR and FDA; for example internal auditing, non-conformance reporting, data analysis ? Technical/sales More ❯
processes, working with relevant stakeholders to determine root cause and actions required Update tracking and trending spreadsheets for monitoring of QMS processes Perform post-marketsurveillance planning and reporting Provide QA review of procedural updates Support batch review and release inc. review of batch records, QC testing data More ❯
and workplace audits Responsibility for generating and reporting of quality KPIs to Senior Management Manage the Customer Complaint handling through to resolution Perform post-marketsurveillance planning and reporting Provide expert guidance and knowledge to technical and validation teams Provide quality guidance on continuous improvement projects including change More ❯
london, south east england, United Kingdom Hybrid / WFH Options
IXICO
Advanced analytics. Intelligent insights. IXICO plc (AIM: IXI), is a leading neuroimaging Contract Research Organization (CRO), delivering advanced Ai analytical insights in neuroscience to the global clinical trials market. Established in 2004, listed as a public company in 2013, IXICO More ❯