Director of Quality and Compliance

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 https://www.jnj.com

Job Function

Project/Program Management Group

Job Sub Function

Project/Program Management

Job Category

Professional

All Job Posting Locations:

Yokneam, Haifa District, Israel

Job Description

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for QA Director to be in Yokneam.

The Director of Quality and Compliance is responsible for leading, planning, executing, and standardizing the NPD and related LCM policies, processes, and standards at the HTC site. This position oversees the product quality assurance program to prevent or eliminate defects in new and existing products, ensuring the release of safe, effective, and high-quality products compliant with all regulatory requirements.

This role is reporting to Senior Director Quality & Compliance.

Key Responsibilities

Quality and Compliance Management:

• Lead the Quality and Compliance department and ensure compliance with all regulatory requirements and standards.
• Collaborate with business and functional leaders to drive risk mitigation, proactive actions, and continuous improvement.
• Set strategies and goals for HTC Quality and Compliance functions in alignment with applicable regulations.
• Ensure effective implementation of quality compliance policies related to global medical device, safety, and environmental laws.
  
  

• Establish and manage organizations supporting business processes and compliance, including quality risk management, design assurance, internal audits, corrective and preventive actions, records management, and document control.
• Oversee complaint management, medical device reporting, and quality data management across disciplines.
  
  

• Serve as a point of contact for Regulatory Authorities regarding actions and inspections.
• Maintain up-to-date knowledge of international regulations and standards and ensure adherence through the Quality Manual.
  
  

• Ensure compliance with documentation procedures and control, producing end-user documentation for HTC-developed products.
• Manage customer complaints, initiate corrective actions, analyze trends, and interact with NPD project teams to address service needs throughout the project lifecycle.
  
  

• Oversee Quality Engineering functions, including supplier qualification, product release, field actions, and complaint resolution activities.
• Foster collaboration among NPD departments to promote design excellence and quality improvements in new and existing products.
• Define and monitor metrics for Quality Engineering, QS, and Compliance Departments to drive product and system quality improvements.
  
  

• Ensure software quality assurance processes and deliverables comply with process validation and verification standards.
  
  

• Act as a Management Representative or deputy, ensuring the quality management system’s effectiveness and promoting regulatory awareness within the organization.
  
  

• Communicate business-related issues and opportunities to higher management levels.
• Ensure compliance with company guidelines related to health, safety, and environmental practices.
• Develop and coach team members to achieve functional strategies and objectives.
  
  

• Bachelor’s degree in science, engineering, biology, chemistry, or a related technical field.
• Minimum of 10 years of related experience in highly regulated industries (e.g., pharmaceutical, medical device).
• Experience in Electrophysiology and Interventional Cardiology fields is highly preferred.
• Proven leadership experience managing both technical and non-technical staff (10+ years).
• Knowledge of medical device regulations (e.g., 21 CFR 820, EU MDR, ISO60601, IEC62304).
  
  

• Master’s degree in science or engineering.
• Familiarity with A-fib case devices and clinical workflows.
• Experience leading verification/validation engineers or contractors.
  
  

• Advanced critical thinking and investigation skills.
• Strong written and verbal communication and presentation skills.
• Ability to prioritize and manage multiple activities and responsibilities effectively.
• Collaborative and influence management skills.
• Business and compliance acumen with a technical understanding of products and processes.
• Familiarity with GMP, GLP, and/or GCP practices.