Business Services, Continuous Improvement, FDA Requirements, ISO (International Organization for Standardization), Insurance Regulations, Maintain Compliance, Medical Equipment, Quality Assurance, Quality Management, Regulations, Specimen Collection
LOCATION
Burlington, NC
POSTED
1 day ago
List the core tasks and responsibilities associated with the role. - Provide enterprise-wide quality governance for specimen collection kits, ensuring compliance with FDA medical device regulations and ISO 13485 across all functional areas involved in kit lifecycle activities. - Serving as a Management Representative. - Design, implement, and maintain a robust Quality Management System for the centralized specimen collection kit program, including policies, procedures, and controls aligned with regulatory and business needs. - Serve as Quality subject matter expert for specimen collection kits, partnering closely with Regulatory Affairs to ensure aligned interpretation and application of regulatory and quality requirements. - Collaborate with the Director, Regulatory Affairs, Centralized Specimen Collection Kit Program, to ensure seamless integration of regulatory and quality strategies, decision-making, and governance. - Oversee and ensure quality oversight of kit lifecycle processes ...Quality Assurance, Director, Assurance, Regulatory, Continuous Improvement, Quality, Business Services