Senior Director Quality Post-Market Surveillance and Innovation Excellence

Johnson & Johnson • Cherry Hill, NJ

3d

About The Position

The Senior Director, Quality — Post-Market Surveillance and Innovation Excellence is a senior quality executive responsible for shaping and executing the quality strategy supporting the Heart Recovery platform and Innovation Excellence organization. The role provides enterprise-level direction for Complaint Management and Post-Market Surveillance, with accountability for organizational capability, governance, regulatory compliance, and sustained operational performance.

The position establishes an integrated product lifecycle management framework connecting post-market intelligence with risk management, design controls, change control, CAPA, manufacturing, and supply chain quality. Its purpose is to protect patient safety, strengthen product performance, and enable timely, risk-based business decisions across the marketed product portfolio. The position is based in Danvers, Massachusetts, follows the applicable flexible-work arrangement policy, and may require travel of up to 25%.

Requirements

• Bachelor’s degree in engineering, life sciences, biomedical engineering, or a related technical discipline.
• 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.
• 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.
• Success leading cross-functional product lifecycle initiatives and integrating design controls, risk management, CAPA, change control, manufacturing, supply chain quality, and post-market processes.
• 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, including the ability to influence senior stakeholders, navigate ambiguity, lead through change, and communicate complex quality and regulatory matters clearly.

Nice To Haves

• An advanced degree.

Responsibilities

• Serve as the senior Quality leader and strategic advisor to Innovation Excellence, translating business priorities, product risk, and regulatory expectations into an integrated quality strategy and execution roadmap.
• Provide executive oversight of Complaint Management and Post-Market Surveillance, developing accountable teams through clear priorities, governance, talent development, succession planning, and measurable objectives.
• Define the organizational capability strategy for Post-Market Surveillance and Innovation Excellence, including operating model, expertise, processes, systems, and capacity.
• 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 and drive systemic corrective and preventive actions that reduce repeat events and improve product performance, safety, and compliance.
• Support design, implementation, and governance of an integrated lifecycle management framework connecting complaint handling, Post-Market Surveillance, risk management, design controls, change control, CAPA, manufacturing, and supply chain quality.
• Establish cross-functional decision rights, handoffs, acceptance criteria, and verification strategies for product and process changes.
• Champion fit-for-purpose quality systems, digital capabilities, data governance, and analytics that provide closed-loop traceability from field observations through 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 provide quality leadership for regulatory submissions, safety communications, and commitments associated with post-market findings.
• Establish and communicate performance indicators, dashboards, and management reviews for complaints, Post-Market Surveillance, CAPA effectiveness, lifecycle management, and organizational health; use insights to guide prioritization, investment, and continuous improvement.
• Represent Quality in senior leadership forums and influence decisions by balancing patient safety, product performance, compliance obligations, operational feasibility, and business continuity.

Benefits

• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligibility to participate in the Company’s long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
• Holiday pay, including Floating Holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
• Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
• Caregiver Leave: 80 hours in a 52-week rolling period.
• Volunteer Leave: 32 hours per calendar year.
• Military Spouse Time-Off: 80 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior