Software Quality Engineer
Healthcare / Medical Devices
An excellent opportunity for an experienced software quality assurance/ quality engineer professional to join an established diagnostics company who are continuing to grow.
This is a great time to join the business as they continue to innovate and push new product development within a rapidly developing and fast paced niche of healthcare technology.
They are now looking for someone to take the lead on software quality assurance and make an immediate impact on improving the strategy and processes for software quality, design control and computer software validation- working to IEC 62304 and ISO 13485 requirements.
Software Quality Engineer responsibilities
- Process and System Development: supports the development and maintenance of appropriate software design lifecycle processes, required for compliance with regulations which primarily include ISO 13485; IEC 62304; 21 CFR Part 820 & Part 11.
- Design Control Projects: Works directly with the design & development teams to support compliance with design control requirements specifically for embedded device software.
- Computer Systems Validation (CSV): Responsible for generating, maintaining and improving CSV procedures.
Responsible for planning, coordinating and executing all relevant Computer Systems Validation (CSV) activities for the Quality Management System- also creating and maintaining records with the CSV life cycle.
- Non-Conformance Management & Audits: Supports the management of any software related deviations, quality issues or non-conformances and resulting CAPAs.
Experience and Skills required:
- You will have established Software Quality Assurance track record with experience and knowledge ideally from within Diagnostics or Medical Device organisation (or a similar regulated health industry: biotechnology, pharmaceuticals)
- ISO 13485 (Medical Devices – Quality Management Systems)
- IEC 62304 (Medical Device Software – Software Lifecycle)
- US FDA 21CFR Parts 820 (Quality System Regulation)
- Able to demonstrate a full understanding of software lifecycle development and testing processes.
- Able to demonstrate awareness in the use of: ISO 14971 (Risk Management) and AAMI TIR36:2007 (Validation of software for regulated processes)
If you are interested in this Software Quality Engineer opportunity, please contact James Powell here at TXM Recruit.
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.