Senior Director, Quality Systems Strategy – MedTech

Johnson & Johnson Innovative Medicine; Danvers (MA); On-site; USD 178,000 - 307,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Director, Quality Systems to lead the design, implementation, and ongoing optimization of the QMS for the Heart Recovery platform and support the broader Quality & Compliance organization.

This role ensures product quality, regulatory readiness, operational excellence, and a high-performing team across development, manufacturing, and post-market activities for cardiac therapies and devices.

Qualifications

• Demonstrated experience developing and executing enterprise/platform-level quality strategy and leading organizational development for quality functions.
• Deep familiarity with QMS standards and regulations: ISO 13485, FDA QSR/21 CFR Part 820, EU MDR, GMPs and other applicable international regulations or directives.
• Proven record managing external regulatory or notified body inspections.
• Strong cross-functional influence, communication and stakeholder management skills.
• Bachelor’s degree in engineering or life sciences; 12+ years in quality systems; 5+ years in leadership.

Responsibilities

• Define, maintain and scale the platform QMS strategy aligned with objectives and regulations.
• Oversee core QMS processes: Document control, CAPA, change control, Training and Escalation.
• Provide advisory support to QMS elements across Design and Product Lifecycle Management.
• Ensure comprehensive Inspection Readiness with Regulatory Compliance.
• Develop and lead multi-year quality strategy and roadmap for Heart Recovery.
• Build and operationalize sustainable organization plan for the Quality Systems team.
• Own workforce budgeting and prioritization for quality investments.
• Lead capability-building initiatives to raise Quality Systems maturity.
• Drive harmonization of policies, procedures and metrics across geographies.
• Define and govern quality KPIs for senior leadership and boards.
• Lead strategic initiatives to drive operational excellence and CI of the QMS.
• Implement and optimize digital quality tools and dashboards.
• Ensure on-time execution of internal and external audit CAPAs and actions.
• Translate policies into pragmatic, risk-based procedures for development and commercialization.
• Recruit, coach and develop a high-performing Quality & Compliance organization.
• Champion a culture of Quality and patient safety.
• Travel up to 25% as needed.

Skills

Agile Decision Making

Collaboration

Compliance Management

CAPA

Data Quality

Developing Others

Incident Management

Inclusive Leadership

Leadership

Operations Management

Performance Measurement

Quality Control

Quality Management Systems

Quality Services

Quality Standards

Risk Management

Succession Planning

System Integration

Systems Analysis

Tactical Planning

Education

Bachelor’s degree in engineering, life sciences, biomedical engineering, or related technical field

12+ years of progressive quality systems experience in medical devices or related regulated field; minimum 5 years in senior leadership

Job description

Johnson & Johnson is seeking a Sr. Director, Quality Systems to lead the design, implementation, and ongoing optimization of the QMS for the Heart Recovery platform and support the broader Quality & Compliance organization.

This role ensures product quality, regulatory readiness, operational excellence, and a high-performing team across development, manufacturing, and post-market activities for cardiac therapies and devices.