Back to jobs Complaint investigation, coding, and returned product analysis: Own end-to-end execution and oversight of complaint investigations, including robust root cause analysis, consistent and accurate coding, and returned product analysis (RPA) where applicable. Ensure investigations are thorough, timely, and compliant, and drive meaningful conclusions that enable product and process improvements.
Complaint data analysis, trending, and signal identification: Lead the team responsible for analyzing complaint and returned product data to understand device performance, identify trends, and detect potential signals. Establish the governance, methods, and tools needed to support timely escalation, sound decision-making, and appropriate follow-through, including linkage to CAPA, risk management, design changes, and field actions when needed.
Quality Management System (QMS) leadership (site and division): Own and govern assigned QMS processes and performance for a site and the Interventional Cardiology and Vascular Therapies division, ensuring procedures, controls, metrics, audit readiness, and continuous improvement are in place and effective. Drive alignment and harmonization with enterprise QMS requirements and ensure effective interfaces between complaint investigation, CAPA, risk management, and management review.
New products and acquisitions integration: Provide Post Market/Quality Systems Management leadership for acquisition due diligence, integration, and ongoing sustainment.
Infrastructure and project management: Lead projects and programs, in partnership with Quality Assurance colleagues and cross-functional teams, to ensure the organization has the infrastructure, systems, and tools needed to deliver strategic initiatives and business goals. Identify gaps, prioritize improvements, and drive execution of solutions locally and as part of broader global programs.
Enterprise-level shaping: Shape enterprise quality strategy, standards, and operating models by representing divisional and site priorities in enterprise decisions. Partner across functions and divisions to drive alignment, standardization, and scalable solutions that advance business, regulatory, and patient needs.
Strategic decision making: Make clear, timely, risk-based decisions across complaint handling, QMS governance, and business priorities. Apply sound judgment to complex issues, identify and escalate risk as appropriate, drive actions to resolution, and influence leadership to align on decisions that protect patients, ensure compliance, and support performance.
People leadership: Lead, develop, and empower the team to achieve goals, deliver high-quality outcomes, and build organizational capability. Foster a culture of accountability, collaboration, and continuous improvement while supporting talent development, succession planning, and strong performance management.
Collaborate with stakeholders: Partner with leaders across Quality, Regulatory, R&D, Manufacturing, Clinical, and Risk Management to drive consistent Quality System execution and high-quality complaint investigations and trending. Align on investigation priorities, data needs, escalation criteria, and timely actions such as CAPA, risk updates, and design or process improvements. Collaborate with quality peers to share best practices and promote alignment across the organization.
