Senior Director Quality Systems & Strategy (MedTech)

Location: Danvers, Massachusetts, United States of America; travel up to 25% to sites, suppliers, and regulatory meetings

Salary: $178,000–$307,050 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including cardiac therapies and devices.

What you will do

• Lead the design, implementation, maintenance, and continuous optimization of the Quality Management System for the Heart Recovery platform.
• Develop and execute a multi-year quality strategy and roadmap aligned with clinical, scale-up, and commercialization milestones.
• Oversee document control, CAPA, change control, training, escalation, audit corrective actions, and inspection readiness.
• Build the Quality Systems organization, including workforce planning, capability development, budgeting, and leadership development.
• Govern quality KPIs, dashboards, policies, procedures, and continuous-improvement initiatives across geographies and business units.
• Partner with cross-functional stakeholders and advise on quality requirements across product development, manufacturing, and post-market activities.

Requirements

• Bachelor’s degree in engineering, life sciences, biomedical engineering, or a related technical field; an advanced degree is preferred.
• 12+ years of progressive quality systems experience in medical devices or a related regulated field, including at least 5 years in senior leadership.
• Experience developing enterprise- or platform-level quality strategy and leading organizational development for quality functions.
• Deep knowledge of ISO 13485, FDA QSR/21 CFR Part 820, EU MDR, GMPs, and other applicable international regulations.
• Experience managing external regulatory or notified-body inspections.
• Strong cross-functional influence, communication, and stakeholder-management skills.

Nice to have

• Advanced degree in a relevant technical discipline.
• Experience with digital quality tools, data-driven dashboards, and quality-system optimization.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, patient safety, product integrity, and ethical compliance.
• Participation in a pension and 401(k) savings plan.
• Eligibility for the long-term incentive program.
• Vacation, sick time, holidays, parental leave, caregiver leave, volunteer leave, and other time-off benefits.