Senior Director Design Quality

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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 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 :

$196,000.00 - $342,700.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the