The Quality Assurance Engineer will lead and support Quality Assurance activities that ensure compliance with U.S. and international regulations, standards, and guidance related to Class II medical devices.
Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications.
In this role, the selected candidate will actively participate in the analysis of requirements, design, test, deployment, and support of new technology solutions; develops functional specifications and system design specifications for client engagements.
Interact with product management, project management and test teams to develop a strong understanding of the project and testing objectives; design and create test conditions and scripts to address business and technical use cases.
The incumbent is primarily responsible for the design, development, execution and documentation of QA use cases/test scripts, focusing on automating the process. Additionally, this position will work in partnership with other members of the quality assurance and development teams to assist in delivering reliable and accurate end-user experience.
In this role, the selected candidate will develop test plans, test cases and test scripts based on evolving use cases and product requirements; estimate, prioritize, plan, and coordinate testing activities.
Review and monitor service release activities, including but not limited to: matrices setup; mortgage servicing system setup and header creation; service release notifications, purchase advice exception review, and clearing of exceptions; review of output reports for service release transactions; reconciliation and wire funds.
In this role, the selected candidate will be responsible for Key projects in the company's data protection suite for product certification; the tasks given to you will require in depth knowledge and experience on Microsoft Exchange.
In this role, the selected candidate will define the To-be state of business process and workflow as expected by customer (user and IT teams) along with thought leadership inputs, refinements and improvements which will help the customer to achieve objectives faster and in efficient manner.
In this role, you will partner with manufacturing to implement process improvements and address quality events including non-conformance, product disposition, root cause investigation, and laboratory OOS.