Quality Assurance Team Lead

Description:

We at Biosense Webster are looking for a Quality Systems Team Leader.

Biosense Webster R&D Haifa Technology Center (HTC) Part of Johnson & Johnson family of companies, located in Yokneam, Israel.

The Biosense Webster teams partner with leading physicians from around the globe to develop innovative MedTech solutions that improve the quality of care for patients worldwide.

The company's work is built on a proud legacy of leadership in electrophysiology. What began in the 1990’s with the founding of Biosense has evolved to present-day expertise driving best-in-class solutions in cardiac ablation, stroke care, intracardiac imaging and navigated ENT surgery.

Innovation is at the forefront at the Haifa Technology Center. Biosense Webster has been the top patent applicant in Israel for a decade. To fuel its innovation, experts in systems engineering, software integration, image integration, ultrasound capabilities, 3D printing and miniature sensors work collaboratively to create solutions that improve physician workflow and patient outcomes. Biosense Webster is also embracing the future of patient care by pioneering next-generation digital solutions, such as cloud-based applications that are powered by artificial intelligence.

A culture of continuous learning gives Biosense webster employees fresh perspective to fuel continuous innovation and growth. The company embraces the unique perspectives, backgrounds and ideas of its employees, and provides them a fascinating career path and an opportunity to impact patients' lives.

In this position you will be asked to:

• Lead the department's employees
• Drive successful and effective results as Site’s CAPA Process Leader:
• Provide professional and management support to Quality System specialist with CAPA activities, including CAPA meetings, action items and CAPA processes (e.g., investigation, implementation, and effectiveness)
• Engage, monitor, and manage an effective CAPA Process including managing / participating in CAPA Meetings to ensure timely closure of open CAPA’s.
• Provide support to CAPA owners and work with global partners.
• Monitor CAPA progress while ensuring completeness and timeliness.
• Meet and maintain Company established Metrics goals and targets for closing CAPA’s.
• Ensure adequacy and compliance with Quality Agreements:
• Ensures Quality Agreements are followed by establishing supporting processes.
• Provide support to Quality System Specialist and professional guideline SMEs and work with global partners.
• Responsible to verify Quality Agreement adequacy to company processes.
• Quality & Compliance training and coaching:
• Provide professional and management support to Training Coordinator training activities and processes.
• Responsible for Quality/cGMP training
• Provides leadership for compliance awareness.
• Assess, plan, implement, and ensure compliance with current local, international, corporate, and company, Quality System and J&J Internal standards.
• Maintain and enforce the Quality Manual and other SOPs.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
  
  

• Degree in engineering or life science.
• Preferred : CQE certification
  
  

• At least 5 years’ experience in the medical device industry or pharmaceutics.
• Experience as Quality Leader and/or quality assurance leader responsible for Quality Audits management.
• Experience working with Notified Bodies, FDA and/or other authorities.
• Experience managing international multi-disciplinary projects.
• Experience with ISO and/ or QSR standards/regulations for the medical
  
  

• Experience with CAPA execution in medical devices and/or pharmaceutics company. – Preferred
• Quality Standards requirements: high level
• Data Analysis Statistical Tools – preferred
• Very Good written and verbal English skills
• Experienced trainer – preferred
• Certified Lead Internal Quality Auditor - preferred