• Apply specialized knowledge to perform tasks and achieve objectives in the Complaints discipline
• Process, investigate, and monitor trending and reporting of product defect complaints, serving as the primary contact
• Align with Medical Safety and/or Research and Development on adverse events
• Address and expedite product complaints under the company’s complaint policy and procedures
• Ensure compliance with regulatory agencies’ reporting requirements
• Follow procedures with some decision-making authority, requiring job-related training, attention to detail, and reliability
• Support complaint activity monitoring and provide suggestions to modify existing manufacturing or packaging processes
• Maintain unified product defect investigation operating procedures
• Collaborate with cross-functional teams to drive problem-solving and innovation through scientific principles
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs)
• Maintain accurate and complete documentation and ensure rigorous quality control
• Complete all required training and meet individual job requirements to contribute to the overall compliance of the organization
• Commit to continuous improvement in operationsAll associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.