- To set up and maintain a suitable Quality Management System to ISO 13485:2016
- To assist with development and updates to the Quality Manual
- To direct processes and procedures to set up the laboratory to ISO 15189
- To assist with external auditor procedures and conduct internal audits of the Quality Management System including Quality Procedures and the SOP system.
- Setting up of an appropriate EN ISO 13485 and EN 62304 compliant quality management system to support regulatory objectives
- Close working relationship with developers, scientists and technician staff to instruct in the requirements and standard expected within a QMS
- Keep up to date with QMS legislative changes
- Responsible for the continued implementation and maintenance of the QMS described in the quality manual
- Identify and record problems concerning products, processes and systems, and implementing and verifying solutions
- Manage company activities to control the processing and prevent delivery of non-conforming products
- Ensure that processes needed for the QMS are established, implemented and maintained
- Report to directors on the performance of the QMS and suggesting improvements
- Promote awareness of regulatory requirements throughout the organisation
- Strong evidence of setting up and managing a QMS
- Experience of working in the IVD medical device field, implementing the requirements of ISO 13485:2016 AND/OR experience of working with software life cycle QMS (ISO 13485) or IEC62304:2006
- Good working knowledge of the MDD 93/42/EEC and IVDD 98/79/EEC regulations and current transitional arrangements
- Experience of working with notified/regulatory bodies eg MHRA and BSI
- Evidence of working to highest standard independently, with superior organisational abilities
- Excellent communication skills including the ability to explain quality management effectively and engage with various disciplines- scientists, technicians and business
- Motivated and inspired with an innovative approach to work
- Freelance Senior CRA
Job location: United Kingdom
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