Senior Software QA consultant
Our partner is a highly innovative company operating worldwide.
We have an immediate need for a Senior level Software QA consultant for supporting our partner their software solutions. The product has both IVD and RUO versions, and is a SaaS solution with deployments worldwide. They operate under an ISO 13485 certified quality system, and within an ISO 27001 certified Information Security Management System.
We would start with a 6 month engagement the development, release, and operations for their platform, under our ISO 13485-certified QMS and ISO 27001 ISMS.
- QA support for new software product releases are taken from concept, design, development to commercialization. In a year we have about 20-25 software releases in Leuven
- Health Hazard evaluations associated with the complaints
- Safety and non-safety customer notifications
- Tracking and trending of Quality objectives on weekly and monthly basis
- Supporting site notified body and internal audits
- Develops, implements and maintains Quality Management system and activities within FDA QSR 820, ISO 13485, ISO 27001 and international regulatory guidelines
- Assist in development and execution of regulatory plans for complex projects. Assist in documentation for regulatory meetings with FDA.
- Assist in complaints investigation, CAPA, Non- Conformances and Deviations.
- Review and approve change requests and Change Orders.
- Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards.
- Create and / or update design and process FMEA. Review, create, and / or update traceability matrices.
- Support Computer Systems Validation activities
- Contribute to QMS updates and tools implementations supporting our transition to IVDR