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.
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.
The Quality Engineer supports the validations of a designated business unit or specialty, including the planning, writing and data analysis for validations. The QE uses technical writing skills, statistics and other tools to implement products and processes to support production and laboratories.
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.
Perform analysis using analytically and physical equipment to assure compliance to specification. Specialized equipment used includes ph meter, oxygen meter, titration for chlorine and acid, and measurement tools.
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.
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.
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.
Plan validation scope for product and process launches Write protocols and reports demonstrating solid technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated