Director of Quality and Compliance

Johnson & Johnson is currently seeking a Director of Quality and Compliance to join our team located in Yokneam, Israel.

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 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.

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 Engineer...