Quality Assurance Specialist (Complaints) - (Portsmouth, NH)

This position is responsible for supporting Novocure's quality technical complaint system activities in the Portsmouth, NH facility reporting to the Global Complaint Manager. Essential Duties and Responsibilities: Complete regulation reporting determinations at the initiation of complaint. Assure complaint workflows with multiple hand-offs meet process cycle time expectations within SAP ECC. Performing CAPA Evaluations within complaints utilizing record specifics and tracking/trending data. Direct communication with the Global Technical Support Engineer to insure alignment for complaint investigations Ensure complaint process meets compliance against released procedures and related standards/regulations Identify when process performance shifts occur and communicate same Involvement with process re-design by assisting with writing/updating process documentation as needed. Other activities as assigned (i.e. involvement with CAPAs related to Complaint Handling, Internal Auditing) Requirements: