Senior Director Design Quality

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

People Leader

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

Senior Director Design Quality

Job Summary

The Senior Director, Design Quality will report directly to the Vice President, Quality & Compliance for the Heart Recovery business. This role is responsible for providing strategic and operational leadership for Design Quality across the product lifecycle, including new product development, sustaining engineering, design changes, and lifecycle management activities. The Senior Director, Design Quality will partner closely with Research & Development, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, Risk Management, and Commercial teams to ensure products are designed, developed, and maintained in compliance with applicable global regulations, standards, and Johnson & Johnson quality requirements. This leader will establish and maintain an effective Design Quality organization that enables innovation while ensuring patient safety, product quality, and regulatory compliance.

Duties & Responsibilities

In accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• Responsible for communicating business-related issues or opportunities to the next management level.
• Provides strategic leadership for Design Quality across the Heart Recovery product portfolio.
• Leads and develops a high-performing Design Quality organization supporting product development, sustaining engineering, and lifecycle management activities.
• Establishes Design Quality strategies, objectives, and key performance indicators aligned with business and quality goals.
• Ensures design control activities comply with FDA Quality System Regulation, ISO 13485, EU MDR, MDSAP, and other applicable global regulatory requirements.
• Provides quality oversight for new product development activities, including design planning, risk management, verification, validation, design transfer, and commercialization.
• Partners with R&D leadership to drive a quality-by-design culture throughout the product development lifecycle.
• Ensures effective implementation of design control procedures, software lifecycle processes, usability engineering, cybersecurity requirements, and risk management activities.
• Provides independent quality assessment and decision-making during design reviews, phase gate reviews, and product lifecycle governance processes.
• Supports regulatory submissions, product approvals, and regulatory agency interactions related to product development and design quality matters.
• Collaborates with post-market surveillance, complaints, CAPA, and field quality organizations to drive continuous product improvements and risk mitigation strategies.
• Represents Design Quality during internal audits, external inspections, notified body audits, and regulatory agency interactions.
• Drives organizational excellence through continuous improvement initiatives focused on product quality, compliance, and operational effectiveness.
• Ensures talent development, succession planning, and organizational capability development within the Design Quality function.
• Supports strategic business initiatives and acquisitions by providing Design Quality expertise and integration support as required.
• Responsible for following all Company guidelines related to Health, Safety, and Environmental practices, as applicable.
• Responsible for ensuring personal and organizational compliance with all Federal, State, local, and Company regulations, policies, and procedures.

Experience and Education

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline required.
• 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 commercializatio