Director of Quality and Compliance

Johnson & Johnson

4.2

(92)

Yokne'am Illit, Israel

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2406226686W

    Position summary

    ty 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. #LI-LM5

    Qualifications

    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.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.