Quality Specialist or Quality Manager - IVD or Software as Medical Device

Our client is a business with a purpose: Reducing the mortality rate of patients with cancer through early detection. They are developing a non-invasive, blood-based diagnostic for the early detection of cancer. Their test analyses cancer-driven metabolic activity in blood, which their AI software is trained to then interpret and diagnose- amazing right?!  

They are beginning the regulatory journey to market supported by a highly specialised regulatory consultancy team. This unique offering brings together innovative IVD hardware with AI software platforms as medical devices, at a challenging time of regulatory change for the UK and the EU.
 

We are therefore seeking a Senior Quality Specialist or Quality Manager with prior experience of laboratory based QMS and IVD, who wants to help build a successful business. This person will work with technical and data scientists, clinicians, technicians and directors to map out the process from sampling to reporting. Reporting to the CEO, this person will select and build the Quality Management System to underpin the journey to UKCA/CE marking for the technology.
 

Key Objectives:

• 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.

Key Responsibilities:

• 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

Desirable Knowledge, Skills and Experience :

• 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

This is a fabulous opportunity to be part of a growing award-winning organisation focussed on patient outcomes. Salary and benefits are negotiable based on experience, and the role will be based from home with occasional trips to the office in Swansea.
 

If you are excited by working in a company with a vision that you can help shape, and feel your values are aligned, please apply today or contact Katie Dunbar on +441273 952176 for more information.