I am partnering an exceptionally successful, rapidly growing Artificial Intelligence Healthcare focused technology and product organisation who have won numerous awards recognising their rapid growth, technology and for leading in their field since their inception to find a hands-on Senior Quality Systems Lead based in South West London.
They are a team on a mission, to put accessible and affordable healthcare in the hands of every person on earth. Their mission is bold and ambitious, and it's one that's shared by their team who epitomise our values, to dream big, build fast and be brilliant.
The Senior Quality Systems Lead will be reporting into the Head of Quality with a dotted line to technical C-Level management and have responsibility for leading on Quality Processes, continuous improvement, CAPA's and Risk Management predominantly.
* Manage the ongoing internal audit schedules, and the required rectification plans for any non-conformance's discovered
* Find ways to continually improve the company's processes through engagement with the senior/executive leadership team
* Ensure the company stays up to date with changes to standards and key regulations
* Be a Subject Matter Expert and point of contact for the teams when a question around process, security and/or risk is raised
* Demonstrable background in Quality Assurance positions
* In depth knowledge of ISO 13485
* A background in Healthcare/Life Sciences/Pharmaceutical/Medical Devices/Digital Health
* Understanding of international standards including the FDA (21 CFR 820 etc), IEC 62304 and IO 14971
* Cyber-security experience
* Background working in an Agile software development environment
* Relevant Quality related Qualifications or memberships
If this opportunity aligns with your career aspirations apply now!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales