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 Summary

The Director of Quality and Compliance is responsible for leading, planning, executing, and standardizing the NPD and related LCM policies, processes, and standards at Yokneam 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.
• Quality Services:
• 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.
• Regulatory Interface:
• 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.
• Documentation and Customer Complaints:
• 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.
• Quality Engineering:
• 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.
• Software Quality Assurance: Ensure software quality assurance processes and deliverables comply with process validation and verification standards.
• Management Representation: Act as a Management Representative or deputy, ensuring the quality management system’s effectiveness and promoting regulatory awareness within the organization.
• Leadership and Communication:
• 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.

Experience and Education:

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

Skills and Abilities:

• 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.

Why Join Us?

At J&J MedTech you will have the opportunity to lead quality and compliance efforts at the forefront of medical device innovation, contributing to life-saving technologies. Join a dynamic team dedicated to excellence in a highly collaborative environment.