Senior Director, Quality Systems Strategy

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

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking a Sr. Director of Quality Systems to lead design, implementation, and continuous improvement of the Quality Management System for the Heart Recovery platform.

You will own strategy development, regulatory readiness, and a scalable quality organization across development, manufacturing, and post-market activities for cardiac therapies and devices. This role reports as Management Representative and requires deep QMS expertise (ISO 13485, FDA QSR/21 CFR Part 820, EU

Qualifications

• 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.

Responsibilities

• Define, maintain and scale the platform QMS strategy aligned with corporate objectives and applicable regulations.
• Oversee core QMS processes: Document control, CAPA, change control, Training and Escalation processes.
• Provide advisory support to QMS elements associated to Design and Product Lifecycle Management as required.
• Ensure an Inspection Readiness plan in collaboration with Regulatory Compliance.
• Develop and lead the multi-year quality strategy and roadmap for the Heart Recovery platform.
• Build and operationalize a sustainable organization plan for the Quality Systems team.
• Own workforce planning, budgetary planning, and prioritization for quality investments.
• Lead capability-building initiatives to raise Quality Systems and compliance maturity.
• Drive harmonization and standardization of policies, procedures, and metrics.
• Define and govern quality KPIs and governance cadence for the organization.

Skills

Quality strategy

Regulatory compliance

Leadership

Cross-functional coordination

Education

Bachelor's degree in engineering

Life sciences or related field

Job description

Johnson & Johnson is seeking a Sr. Director of Quality Systems to lead design, implementation, and continuous improvement of the Quality Management System for the Heart Recovery platform.

You will own strategy development, regulatory readiness, and a scalable quality organization across development, manufacturing, and post-market activities for cardiac therapies and devices. This role reports as Management Representative and requires deep QMS expertise (ISO 13485, FDA QSR/21 CFR Part 820, EU