QA Engineer 2

This functional department provides technical support and guidance to product teams to ensure conformance to product development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971). We are responsible for various aspects of Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Product HW/SW Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering and others). We work closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to established standards and agency regulations.