This position supports the QA department responsible for Grinding, Separating Process, Bulk, and Pyro equipment. This position requires the person to possess expert knowledge of an SAP Quality Module business system, analyze non-conformances and supplier performance rating data, perform document control and global library management, and write QA system procedures, and project quality plans.
In this position, you will ensures the CAPA system activities are in compliance with all applicable FDA quality system regulations as well as ISO 13485 and ISO 9001 in support of ASR, GPR, and IVD Class I, II and III products
Provide QA resource to product support to ensure regulatory compliance of post market products; ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations.
The Quality Assurance Analyst's role is performing IT application system testing, providing production support and performing business analysis; this will include writing functional and regression testing plans, executing the test plans, and reporting and tracking defects to resolution.
In this role, you will be responsible for testing the database logic, quality, performance, workflows and reports ensuring they meet the business requirements and acceptance criteria prior to release and after release into user facing environments.
The IT Quality Assurance Ad visor should be able to actively participate in leadership meetings and project discussions and should be able to contribute to strategic planning and execution of all QA management tasks.
Participate/coordinate root cause failure analysis of nonconforming material with Manufacturing Engineering and the supplier to determine product quality (including situations where limits may not be clearly defined).