Senior Director Design Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Bachelors 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 commercialization.

Strong knowledge of FDA regulations ISO 13485 ISO 14971 IEC 62304 IEC 62366 EU MDR and global quality system requirements.

Experience supporting regulatory inspections and external audits.

Experience leading large global cross-functional teams in a matrix environment.

Cardiovascular and/or heart failure device experience strongly preferred.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES AND AFFILIATIONS

Expert knowledge of Design Controls and Risk Management principles.

Strong strategic thinking and executive leadership capabilities.

Proven ability to influence and collaborate across complex matrix organizations.

Demonstrated ability to drive organizational change and continuous improvement initiatives.

Strong verbal and written communication skills with the ability to present effectively to senior leadership and regulatory agencies.

Demonstrated problem-solving and decision-making capabilities in highly regulated environments.

Strong business acumen and customer-focused mindset.

Effective talent management coaching and organizational development skills.

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

Passion for advancing patient outcomes through heart recovery technologies.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

Leads a global Design Quality organization supporting all Heart Recovery product development and sustaining engineering activities.

Directly manages Design Quality leaders and professionals.

Collaborates extensively with R&D Regulatory Affairs Clinical Systems Engineering Manufacturing Operations Quality Supplier Quality Post-Market Surveillance Medical Safety and Commercial organizations.

Regularly interfaces with executive leadership and business stakeholders regarding product quality compliance and development strategy.

LOCATION & TRAVEL REQUIREMENTS

Domestic and international travel up to 25%.

EXTERNAL INTERACTIONS

FDA and other global regulatory agencies.

Notified Bodies and third-party auditors.

External consultants and industry experts.

Clinical investigators and healthcare providers.

Industry standards organizations and professional associations.

Required Skills:

Preferred Skills:

Agility Jumps Collaboration Compliance Management Continuous Improvement Corrective and Preventive Action (CAPA) Developing Others Inclusive Leadership Leadership Performance Measurement Product Strategies Quality Control (QC) Quality Control Testing Quality Management Systems (QMS) Quality Standards Standard Operating Procedure (SOP) Succession Planning Training People

The anticipated base pay range for this position is :

$196000.00 - $342700.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:
Vacation 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay including Floating Holidays 13 days per calendar year
Work Personal and Family Time - up to 40 hours per calendar year
Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Exec