Senior Director Quality Post-Market Surveillance and Innovation Excellence

Quality

Customer/Commercial Quality

People Leader

Danvers, Massachusetts, United States of America

The Senior Director, Quality — Post-Market Surveillance and Innovation Excellence is a senior quality executive responsible for shaping and executing the quality strategy that supports the Heart Recovery platform and Innovation Excellence organization. This leader provides enterprise-level direction for Complaint Management and Post-Market Surveillance, with accountability for organizational capability, governance, regulatory compliance, and sustained operational performance. The role establishes an integrated product lifecycle management framework that connects post‑market intelligence with risk management, design controls, change control, CAPA, manufacturing, and supply chain quality to protect patient safety, strengthen product performance, and enable timely, risk‑based business decisions across the marketed product portfolio.

• Serve as the senior Quality leader and strategic advisor to the Innovation Excellence organization, translating business priorities, product risk, and regulatory expectations into an integrated quality strategy and execution roadmap.
• Provide executive oversight of the Complaint Management and Post-Market Surveillance organizations, building high‑performing, accountable teams through clear priorities, strong governance, talent development, succession planning, and measurable performance objectives.
• Define and advance the organizational capability strategy for Post‑Market Surveillance and Innovation Excellence, ensuring the operating model, expertise, processes, systems, and capacity are positioned to meet evolving business and regulatory needs.
• Partner with Innovation Excellence, Sustaining Engineering, Regulatory Affairs, Research and Development, Manufacturing, Medical Safety, Supply Chain, and Quality Assurance leaders to align quality priorities with platform strategy and lifecycle objectives.
• Maintain accountability for the end‑to‑end complaint management process, including intake, triage, investigation, root‑cause analysis, trending, escalation, reportability assessment, and timely regulatory reporting.
• Set the strategic direction and governance for Post‑Market Surveillance, including signal detection, risk assessment, cohort analysis, periodic safety reporting, and recommendations for field actions or other risk‑control measures.
• Ensure timely, risk‑based evaluation and escalation of post‑market issues; drive systemic corrective and preventive actions that reduce repeat events, improve product performance, and strengthen the overall safety and compliance profile.
• Support the design, implementation, and governance of an integrated lifecycle management framework that connects complaint handling, Post‑Market Surveillance, risk management, design controls, change control, CAPA, manufacturing, and supply chain quality.
• Establish clear cross‑functional decision rights, handoffs, acceptance criteria, and verification strategies for product and process changes across Research and Development, Sustaining Engineering, Manufacturing, Regulatory Affairs, and Quality.
• Champion fit‑for‑purpose quality systems, digital capabilities, data governance, and analytics that provide closed‑loop traceability from field observations through design or process changes and verification of effectiveness.
• Maintain inspection‑ready complaint and Post‑Market Surveillance processes, systems, and records in accordance with FDA QMSR, ISO 13485, EU MDR, and other applicable global requirements.
• Lead executive responses to regulatory inquiries; direct inspection‑readiness activities; and…