Participate in product development cycle by reviewing software project documentation, participating in product risk assessments, work closely with R&D to develop appropriate qualifications, verifications, validations, and non-product software, for both new design and changes to released product.
Perform Quality Engineering support for projects in Design Controls processes
Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate engineering methods and techniques.
Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System regarding software and system design.
Support software defects process uncovered during development, testing and post-release.
Provide solutions to a wide range of challenges.
Ensure that FDA, ISO, EU and other global quality standards and regulations are met where applicable.
Training and educating on design controls best practices and SOPs
· Perform DHF audits.
· Lead problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices.