Overview
Reference Number: JO-2308-521483
Quality and Software Consultant
Rate: Negotiable
Job Type: Contract
Location: Central London / West End
Quality and Software Consultant
3 month contract initially, potential for longer
Hourly rate is negotiable depending on experience
Remote
Cpl Life Sciences are partnering with a Medical Devices Software company recruiting for a Quality and Software Consultant. This role will be joining the Research and Development team for developing and testing their STAR mapping software and testing documentation for the system’s regulatory submission.
Key requirements;
- Testing and documentation of the STAR Mapping software for identifying the key sources/drivers from the data acquired using a 3D Electroanatomic mapping system
- Supporting developers with report writing for 2nd FDA submissions
- Working knowledge of Software Requirements Specification (SRS), Product Requirement Specification (PRS), and User Needs (UN) documents, and ability to update the software documentation to match the software
- Working knowledge of Design Control document deliverables and execution.
- Work closely with internal developer, QA and RA to understand the performance, user interface and clinical needs, and perform the software testing and documentation according to the requirements and SOP
- Execute software testing; maintain, update and documents the software requirements, design history files
- Works independently but being impactful to the overall teams’ objective. Is a collaborative team player and demonstrates open-mindedness and flexibility; Consistently promote collaboration, positivity, accountability, and resourcefulness
- Responsible for compliance with Rhythm AI’s quality system procedures and all regulatory requirements
Experience;
- Educated to a PhD/ Bachelors or Masters within a Scientific/ Engineering subject
- Experience with Medical Device software is a necessity
- Experience in delivery of validated and documented software projects whilst working in a regulated industry or environment
- Experience working within regulatory (e.g. ISO 13485) and medical software quality management systems required
For more information please contact Amy.goddard@cpl.com
