The Sr. Quality Systems Quality Assurance Associate is responsible for assisting with the day to day operations related to the Quality Standards program and data analytics within the Quality Systems department.
This position requires an in depth knowledge of US and international medical device regulatory requirements, utilization of Quality Management System methods, including but not limited to, quality system implementation, review of complaints, CAPA, validation protocols and reports, risk management and clinical data.
In this role, you will provide product development protocol requirements for quality standards, inspection techniques and inspection frequencies, lot sizes, statistical analysis, sterility requirements, etc.
In this role, the selected candidate will provide technical/project management direction and assistance to internal/external customers, subcontractors, suppliers and licensees relative to quality related products and services and convince customer that quality problems have been resolved satisfactorily.
In this role, the selected candidate will perform data analysis trending and reporting on key quality system performance metrics (ex. audit observations, corrective action status, non-conformances, CAPA effectiveness).
The Quality Specialist responds to complaints from customers to resolve product quality issues and is responsible for the ongoing development and administration of the supplier quantity rating/reporting system.