Senior Director Quality Post-Market Surveillance and Innovation Excellence

Required Qualifications

• Bachelor’s degree in engineering, life sciences, biomedical engineering, or a related technical discipline; an advanced degree is preferred.
• At least 10 years of progressive quality leadership experience in medical devices (Class III devices), combination products, or another highly regulated industry, including substantial responsibility for complaint management and Post-Market Surveillance.
• At least five years of people-leadership experience directing multidisciplinary quality teams and developing leaders in a complex, matrixed organization.
• Demonstrated expertise in global quality-system and post-market regulatory requirements, including FDA QMSR and 21 CFR Part 820, ISO 13485, EU MDR, and applicable vigilance and reporting obligations.
• Proven success leading cross-functional product lifecycle initiatives and integrating design controls, risk management, CAPA, change control, manufacturing, supply chain quality, and post-market processes.
• Demonstrated ability to translate post-market data, quality signals, and analytics into risk-based executive decisions, strategic priorities, and measurable improvements in patient safety and product performance.
• Strong executive presence and communication skills, with the ability to influence senior stakeholders, navigate ambiguity, lead through change, and clearly communicate complex quality and regulatory matters.

1. 1Serve 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.
2. 2Provide 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.
3. 3Define 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.
4. 4Partner 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.
5. 5Maintain accountability for the end-to-end complaint management process, including intake, triage, investigation, root-cause analysis, trending, escalation, reportability assessment, and timely regulatory reporting.
6. 6Set 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.
7. 7Ensure 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.
8. 8Support 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.
9. 9Establish 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.
10. 10Champion 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.
11. 11Maintain 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.
12. 12Lead executive responses to regulatory inquiries; direct inspection-readiness activities; and provide quality leadership for regulatory submissions, safety communications, and commitments associated with post-market findings.
13. 13Establish and communicate meaningful performance indicators, dashboards, and management reviews for complaints, Post-Market Surveillance, CAPA effectiveness, lifecycle management, and organizational health; use insights to drive prioritization, investment, and continuous improvement.
14. 14Represent Quality in senior leadership forums and influence complex decisions by balancing patient safety, product performance, compliance obligations, operational feasibility, and business continuity.