Senior Director Design Quality – Johnson & Johnson, Danvers,

J&J Senior Director, Design Quality – Johnson & Johnson, Danvers, Massachusetts, USA

Company: Johnson & Johnson (J&J)
Job Title: Senior Director Design Quality
Function: Quality
Sub Function: R&D/Scientific Quality
Job Category: Senior Director, R&D/Scientific Quality (PL10)
Location: Danvers, Massachusetts, United States
Work Pattern: Hybrid Work
Date Posted: October 1, 2026
Requisition Number: R-102648
Required Experience: Minimum 15 years in the medical device industry
Leadership Experience: Minimum 10 years
Salary Range: $196,000–$342,700 per year
Anticipated Closing Date: October 15, 2026, subject to extension
Travel Requirements: Up to 25% domestic and international travel
Apply Online: https://careers.jnj.com/

Job Overview

Johnson & Johnson (J&J) is inviting applications for the position of Senior Director Design Quality in Danvers, Massachusetts, USA. This senior leadership opportunity is intended for experienced medical device quality professionals with extensive expertise in design quality, regulatory compliance, product development, risk management, and global quality systems.

The J&J Senior Director Design Quality position will provide strategic and operational leadership for Design Quality across the Heart Recovery business. The selected candidate will report directly to the Vice President, Quality & Compliance and oversee quality activities throughout the product lifecycle, including new product development, sustaining engineering, design changes, and lifecycle management.

This position requires a strong combination of technical knowledge, executive leadership, regulatory expertise, and cross-functional collaboration. The successful candidate will help ensure that medical devices are designed, developed, and maintained in accordance with applicable global regulations, industry standards, and company quality requirements.

Professionals with experience in Class II and Class III medical devices, cardiovascular technologies, or heart failure devices may find this opportunity particularly relevant.

About Johnson & Johnson

Johnson & Johnson is a global healthcare company focused on innovation across Innovative Medicine and MedTech. Its healthcare technologies and products are developed to address medical needs and support improved patient outcomes.

Design Quality is a critical function in medical technology because product design decisions can influence patient safety, device performance, regulatory compliance, and manufacturing consistency. Strong design controls, risk management, verification, validation, and post-market feedback processes help ensure that medical devices meet their intended requirements throughout their lifecycle.

Key Responsibilities of the Senior Director Design Quality

The J&J Senior Director Design Quality will lead the Design Quality organization supporting the Heart Recovery product portfolio. Major responsibilities include:

• Providing strategic direction for Design Quality across new product development, sustaining engineering, and lifecycle management.
• Building, leading, and developing a high-performing global Design Quality organization.
• Establishing quality strategies, objectives, and key performance indicators aligned with business priorities.
• Ensuring effective design control processes and compliance with applicable FDA requirements, ISO 13485, EU Medical Device Regulation (MDR), Medical Device Single Audit Program (MDSAP), and other relevant global regulations.
• Providing quality oversight for design planning, risk management, design verification, design validation, design transfer, and commercialization.
• Partnering with Research and Development (R&D) leadership to promote a quality-by-design culture throughout product development.
• Overseeing design control procedures, software lifecycle processes, usability engineering, cybersecurity requirements, and risk management activities, as applicable.
• Providing independent quality assessments during design reviews, phase-gate reviews, and product lifecycle governance activities.
• Supporting regulatory submissions, product approvals, and interactions with regulatory agencies.
• Collaborating with post-market surveillance, complaints, CAPA, and field quality teams to identify product improvement opportunities and implement risk mitigation strategies.
• Representing Design Quality during internal audits, external inspections, notified body audits, and regulatory agency interactions.
• Driving continuous improvement initiatives to strengthen product quality, regulatory compliance, and operational effectiveness.
• Supporting talent development, succession planning, and organizational capability building.
• Providing Design Quality expertise for strategic business initiatives and acquisitions, when required.

The role also involves communicating significant business or quality concerns to senior management and ensuring compliance with applicable company policies, health and safety requirements, and environmental practices.

Educational Qualifications

Candidates must have a bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.

A relevant master’s degree may be advantageous for professionals seeking senior leadership opportunities, although the supplied job description specifies a bachelor’s degree as the required qualification.

Experience Requirements

The company specifies the following minimum experience requirements:

• At least 15 years of progressive experience in the medical device industry.
• At least 10 years of leadership experience in Quality, Design Quality, Product Development Quality, or a related function.
• Demonstrated experience supporting Class II and/or Class III medical devices throughout product development and commercialization.
• Experience supporting regulatory inspections and external audits.
• Proven ability to lead large, global, cross-functional teams in a matrix organization.

Experience in cardiovascular devices and/or heart failure technologies is strongly preferred.

Required Technical Knowledge and Skills

Candidates applying for the J&J Senior Director Design Quality position should demonstrate expert knowledge of design controls and risk management principles.

Important technical and leadership capabilities include:

• FDA regulations and global medical device quality system requirements.
• ISO 13485 quality management systems.
• ISO 14971 medical device risk management.
• IEC 62304 medical device software lifecycle processes.
• IEC 62366 usability engineering.
• EU MDR and other applicable international regulatory requirements.
• Product development quality and design verification and validation.
• CAPA, compliance management, and continuous improvement.
• Strategic planning, performance measurement, and organizational development.
• Executive communication, stakeholder engagement, and evidence-based decision-making.
• Talent management, coaching, mentoring, and succession planning.
• Collaboration with R&D, Regulatory Affairs, Clinical, Manufacturing, Supplier Quality, and Post-Market Surveillance teams.

ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or an equivalent certification is preferred.

Leadership and Cross-Functional Collaboration

This position leads a global Design Quality organization supporting product development and sustaining engineering activities across the Heart Recovery business.

The Senior Director will directly manage Design Quality leaders and professionals and collaborate with R&D, Regulatory Affairs, Clinical, Systems Engineering, Manufacturing, Operations Quality, Supplier Quality, Medical Safety, and Commercial teams.

The role also involves regular interaction with executive leadership, FDA and other regulatory agencies, notified bodies, third-party auditors, external consultants, clinical investigators, healthcare providers, and industry standards organizations.

Strong influencing skills, business judgment, and the ability to make independent quality decisions are essential for success in this senior leadership role.

Salary and Benefits

The anticipated annual base salary range for the position is:

$196,000–$342,700 per year.

Actual compensation may vary depending on qualifications, experience, work location, and applicable company policies.

According to the supplied job description, eligible employees may participate in the company’s pension and 401(k) savings plans. The position is also eligible for the company’s long-term incentive program, subject to the applicable plan terms.

The advertised time-off benefits, subject to company policies and eligibility conditions, include:

• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different allowances for certain states as specified in the job posting.
• Holiday pay: 13 days per calendar year, including floating holidays.
• Work, Personal and Family Time: Up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of a qualifying birth, adoption, or foster-care placement.
• Bereavement leave: Up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.

All benefits are subject to the relevant company policies, plan terms, and eligibility requirements.

Job Location and Travel Requirements

The position is based in Danvers, Massachusetts, United States, with a hybrid work pattern. Domestic and international travel of up to 25% may be required.

Candidates should confirm the specific hybrid working arrangements, travel expectations, and any additional employment conditions through the official recruitment portal.

How to Apply for the J&J Senior Director Design Quality Job

Interested candidates can apply through the official Johnson & Johnson careers website.

Application steps:

1. Visit https://careers.jnj.com/.
2. Search for Senior Director Design Quality.
3. Look for requisition number R-102648.
4. Review the complete job description and verify the qualifications and experience requirements.
5. Update your resume to highlight global Design Quality leadership, medical device design controls, regulatory compliance, risk management, and product development experience.
6. Include relevant achievements in team leadership, inspection readiness, continuous improvement, and product lifecycle quality management.
7. Submit your application online if the vacancy remains open.

Anticipated closing date: October 15, 2026. The employer may extend the application period, so candidates should verify current availability on the official careers website.

Frequently Asked Questions (FAQs)

1. What is the job title?

The position is Senior Director Design Quality at Johnson & Johnson in Danvers, Massachusetts, USA.

2. What is the minimum experience required?

A minimum of 15 years of progressive medical device industry experience and 10 years of leadership experience in Quality, Design Quality, Product Development Quality, or a related function are required.

3. What is the advertised salary?

The anticipated annual base salary range is $196,000 to $342,700.

4. Which technical standards are important for this position?

The job description highlights FDA requirements, ISO 13485, ISO 14971, IEC 62304, IEC 62366, EU MDR, MDSAP, and other applicable global regulatory requirements.

5. Is cardiovascular experience required?

Cardiovascular and/or heart failure device experience is strongly preferred.

6. How can I apply?

Visit the official Johnson & Johnson careers website and search for requisition R-102648.

Apply Now

Disclaimer: This job post is prepared from the vacancy information supplied for Pharmaguidances. Applicants should confirm the latest vacancy status, compensation, benefits, and eligibility criteria through the official Johnson & Johnson careers website.

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