Senior Director, Design Quality - Heart Recovery Leader

6942-ABIOMED Inc. Legal Entity; Danvers (MA); On-site; USD 196,000 - 343,000; Full time

Benefits offered by this job

401(k) plan

Pension plan

Long-term incentive

Generous leave

Job summary

Johnson & Johnson in Danvers, MA seeks a Senior Director, Design Quality to lead global Design Quality across the Heart Recovery portfolio, ensuring products meet FDA/ISO standards and patient safety. You will partner with R&D, Regulatory, Clinical, Manufacturing, and Commercial teams to drive design controls, risk management, and lifecycle governance while leading a global team.

This role requires 15+ years in medical devices, 10+ in leadership, and strong regulatory knowledge with CQE/CMQ

Qualifications

• Expertise in Design Controls and Risk Management.
• Strong strategic thinking and executive leadership capabilities.
• Proven ability to influence across complex matrix organizations.

Responsibilities

• Leads a global Design Quality organization for Heart Recovery product development and sustaining activities.
• Partners with R&D, Regulatory, Clinical, Manufacturing, and Commercial teams to ensure compliance and quality governance.
• Drives continuous improvement, design review governance, and risk management across product lifecycle.

Skills

Design Controls

Executive Leadership

Cross-functional

Regulatory Knowledge

CAPA

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Job description

Johnson & Johnson in Danvers, MA seeks a Senior Director, Design Quality to lead global Design Quality across the Heart Recovery portfolio, ensuring products meet FDA/ISO standards and patient safety. You will partner with R&D, Regulatory, Clinical, Manufacturing, and Commercial teams to drive design controls, risk management, and lifecycle governance while leading a global team.

This role requires 15+ years in medical devices, 10+ in leadership, and strong regulatory knowledge with CQE/CMQ