I am partnering with a global Medical Technology organisation to secure a Software Quality Engineer to support their Software-based Medical Device division in North Carolina on a 6 month contract initially.
The Software Quality Engineer will be responsible for providing Quality oversight for product development activities, maintaining the non-product validation program, and coordinating product recall activities.
- Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development
- Serves as the Quality & Regulatory stakeholder for product development release team and a key member of the product risk assessment teams
- Prepares all QARA product development deliverables
- Reviews and approves product design documentation and product documentation to ensure readiness for FDA submissions
- Support root cause analysis activities for the investigation of product complaints
- Assists in the planning and execution of verification and validation testing
- Performs New Product Development gate audits to ensure project deliverables adhere to governing processes
- Responsible for managing all tool and process validations - reviews and approves all validation documentation
- Maintains Master Validation List (MVL) and facilitates annual review of MVL
- Assists with CAPA investigations and ensures corrections and/or corrective actions
- Identifies and implements process improvement initiatives
Experience and Skills required:
- 3+ years' experience in quality engineering role in the Medical Device industry
- Engineering Degree (ie. Electrical, Biomedical) or other technical degree
- Medical Device New Product Development experience
- Experience with software-based products in a regulated industry (ideally IEC 62304 etc)
- Extensive experience with quality tools and methods required (e.g. DFSS, root cause analysis, Software FMEAs etc.)
- Experience with requirements management tools and systems engineering concepts desired
- CQA, CQE or RAC desired
If this is of interest, please apply now!
Interviews are happening 6/27 & 6/28!
Sthree US is acting as an Employment Business in relation to this vacancy.