The Quality Engineer will drive the quality assurance activities in the manufacturing plant. Work with multi-functional teams to develop and implement quality initiatives and make recommendations for improvements.
Actively supporting product development projects by coaching teams to create Project Development Plans, Design Inputs and Outputs, Design History Files, Risk Management, Test strategy, Verification and Validation plans, Test Traceability, etc.
In this role, you will perform QC activities associated with overall reference standard management including inventory, CAPA, deviations, in-country test requests, regulatory support, and review of documents/initiatives/projects.
Determines range and depth of testing activities required including developing more complex test cases, test schedules and prepares test scripts and test data required for testing of software for his/her assigned area(s) of responsibility.
This role is accountable for administering the process control, inspection methods and supplier management and stability program elements of the Quality System to ensure regulatory compliance and robust process design for medical product consumables and reagents.
Performing Incoming Inspection, In-process audits and inspection, and final product inspection in conformance with drawings, Engineering Change Order, workmanship standards and Client policies and procedures.
The Quality Engineer Outage Services will support the Quality System needs of the Outage Services Division and provide a resource for developing and implementing good Quality practices while supporting the Divisions overall business objectives.
Develop and execute automated and performance testing for assigned projects to successfully and consistently enable delivery of high-quality software products and services on time, on budget, and to specification.