Quality Systems Team Leader

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 jnj.com .

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Yokneam, Haifa District, Israel

Job Description:

About Johnson & Johnson MedTech 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 a Quality Systems Team Leader role, to join our team located in Yokneam, Israel.

 

Purpose: Lead the quality systems that help deliver safe, effective medical technologies.

We are looking for a Quality Systems Team Leader to lead key site Quality System processes and a multidisciplinary team. In this role, you will strengthen compliance, improve quality performance, and partner across local and global functions to ensure effective, sustainable processes.

You will be responsible for:

Lead and continuously improve site Quality System processes, with direct ownership of CAPA, Quality Agreements, quality training, the Quality Manual, document and records management, and related procedures.

Manage CAPA governance, including review forums, investigations, implementation plans, effectiveness checks, metrics, escalation, and timely closure.

Ensure Quality Agreements are aligned with company processes, implemented effectively, and supported by appropriate controls and subject-matter expertise.

Lead quality and cGMP training activities, strengthen compliance awareness, and coach employees and process owners on Quality System expectations.

Maintain and improve Quality System procedures in line with applicable regulations, standards, and company requirements.

Provide leadership and governance for cross-functional implementation and ongoing compliance with the J&J Enterprise Retention Schedule (ERS), Legal Hold preservation requirements, and Enterprise Vital Records (EVR) inventory.

Establish expectations, assign ownership, and monitor controls to ensure paper and electronic records are documented, stored, and maintained for validity, accuracy, completeness, consistent retrievability, and compliance with applicable MD-RIC procedures.

Oversee team execution of the physical-records lifecycle, ensuring appropriate controls for active onsite records, transfer of inactive records with required metadata, offsite archiving, and monitoring of archive-box movement.

Ensure the team understands and implements active Legal Hold Notices issued by the J&J Law Department, and monitor compliance with preservation and non-destruction requirements for applicable records, information, and copies.

Partner with local and global stakeholders to resolve quality challenges, identify improvement opportunities, and support audit readiness.

Lead, coach, and develop the Quality Systems team, building capability, accountability, and strong performance.

Monitor key performance indicators, communicate risks and opportunities to management, and drive sustainable corrective and preventive actions.

Perform other duties as assigned based on business needs.

Qualifications and Requirements:

Bachelor’s degree or higher in engineering, science, quality, statistics, or a related field. – Advantage

Certified Quality Engineer (CQE) certification – Advantage

2-4 years’ Experience leading quality assurance or Quality System activities in a regulated environment. - Mandatory

5-7 years’ Working knowledge of medical-device or pharmaceutical Quality System requirements, including ISO standards and Quality System Regulation requirements. - Mandatory

Experience working with regulatory authorities, notified bodies, or external auditors. – Advantage

Demonstrated leadership of people, projects, or cross-functional initiatives. – Advantage

Strong written and verbal English communication skills. - Mandatory

Quality Lead Auditor or Certified Internal Quality Auditor qualification. – Advantage

Experience with data analysis or statistical tools. – Advantage

Experience in designing or delivering quality and compliance training. – Advantage

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Required Skills:

Preferred Skills: