Senior Director Design Quality

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 leade...