Strategic Design Quality Leader – Medical Devices

jj; Danvers (MA); On-site; USD 196,000 - 343,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Long-term incentive program

Vacation 120 hours/year

Parental Leave

Job summary

Johnson & Johnson, a global leader in health care, seeks a Senior Director of Design Quality in Danvers, MA, to drive strategic and operational leadership across the product lifecycle for Heart Recovery products. This role partners with R&D, Regulatory, Clinical, Manufacturing, and Supply Chain to ensure quality, safety, and regulatory compliance from concept to commercialization.

The ideal candidate has 15+ years in medical devices, 10+ years in leadership, and deep expertise in regulatory

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline required.
• Minimum 15 years of progressive experience in medical devices.
• Minimum 10 years of leadership in Quality, Design Quality, or related functions.
• Experience with Class II/III devices through development to commercialization.
• Strong knowledge of FDA regulations, ISO 13485, EU MDR, and global QMS requirements.
• Experience leading large, global cross-functional teams.

Responsibilities

• Leads global Design Quality organization for Heart Recovery product development and sustaining engineering.
• Drives Design Quality strategies, objectives, and KPIs.
• Ensures compliance with design controls, software life cycle, usability, cybersecurity and risk management.
• Supports regulatory submissions and interactions with agencies.
• Interfaces with executive leadership on product quality and development strategy.
• Drives continuous improvement and talent development within Design Quality.

Skills

Design Quality Leadership

Quality Management

Regulatory Compliance

Cross-functional Leadership

Risk Management

FDA Regulations

Executive Communication

CAPA

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Job description

Johnson & Johnson, a global leader in health care, seeks a Senior Director of Design Quality in Danvers, MA, to drive strategic and operational leadership across the product lifecycle for Heart Recovery products. This role partners with R&D, Regulatory, Clinical, Manufacturing, and Supply Chain to ensure quality, safety, and regulatory compliance from concept to commercialization.

The ideal candidate has 15+ years in medical devices, 10+ years in leadership, and deep expertise in regulatory