Senior Director, Design Quality & Regulatory Excellence

Johnson Johnson; Danvers (MA); On-site; USD 230,000 - 320,000; Full time

Job summary

Johnson & Johnson seeks a Senior Director, Design Quality to lead the Design Quality function for the Heart Recovery portfolio. This role ensures products are designed, developed, and maintained in compliance with global regulations and quality standards, partnering across R&D, Regulatory Affairs, Clinical, Manufacturing, and Supply Chain.

The position drives a quality-by-design culture, manages lifecycle governance, and oversees audits, risk management, and continuous improvement initiatives to

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• Minimum 15 years of progressive experience within the medical device industry.
• Minimum 10 years of leadership experience in Quality, Design Quality, Product Development Quality, or related functions.
• Demonstrated experience supporting Class II and/or Class III medical devices through all phases of product development and commercialization.

Responsibilities

• Provide strategic leadership for Design Quality across the Heart Recovery product portfolio.
• Lead and develop a high-performing Design Quality organization supporting product development, sustaining engineering, and lifecycle management activities.
• Establish Design Quality strategies, objectives, and KPIs aligned with business and quality goals.
• Ensure design control activities comply with FDA QSR, ISO 13485, EU MDR, MDSAP, and other global regulatory requirements.
• Support regulatory submissions, product approvals, and regulatory agency interactions related to design quality.
• Represent Design Quality during audits, inspections, and regulatory interactions.
• Drive continuous improvement initiatives focused on product quality, compliance, and operational excellence.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Quality management

Communication

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline

Job description

Johnson & Johnson seeks a Senior Director, Design Quality to lead the Design Quality function for the Heart Recovery portfolio. This role ensures products are designed, developed, and maintained in compliance with global regulations and quality standards, partnering across R&D, Regulatory Affairs, Clinical, Manufacturing, and Supply Chain.

The position drives a quality-by-design culture, manages lifecycle governance, and oversees audits, risk management, and continuous improvement initiatives to