Johnson & Johnson is currently seeking a Quality Operations Team Leader 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 Med Tech, 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/.
Our local company expertise in driving best-in-class solutions in cardiac ablation, stroke care and intracardiac imaging. As a Quality Operations Team Leader, you will be responsible for manufacturing and design transfer activities. Direct responsibility for Quality Control, Final release of goods to be shipped, Calibration & Maintenance management, non-conforming products, TCA Process, Process Validation/ Verification, Operations production stabilization and improvements. Support design transfer process, PFMEA process, Customer complaints, CSA/ UL compliance

Responsibilities:

• Lead the quality operations activities such as calibration, PM, QC & Final release, nonconforming management etc
• Ensure high quality of BWI products, full compliance of products with relevant standards and specifications.
• Manages Qualification and leads validation of manufacturing processes, including Suppliers guidance with Biosense process validation requirements, planning, execution, monitoring, reporting and approval.
• Employ statistical methodologies to support process validation analysis and decision making
• Mentors and trains team members: Directs and guides team members to maximize their personal talents and to develop new skills.
• Subcontractors/ Suppliers Quality evaluation, monitoring and improvement activities.

Qualifications

• At least 3 years of experience in QA field in medical device industry
• BSc in Engineering/ BA degree or Practical Engineering with Qualification in Quality Assurance (CQE).
• Experience with Quality Audits, Quality assurance in manufacturing processes and data statistical analysis.
• Experience in leading multi-disciplinary projects
• Demonstrated knowledge of manufacturing process principles, practices, and procedures
• High Knowledge with quality processes and ability to convert them to company procedures
• Good communication and presentation skills, both verbal and written in English.
• Training/education methodologies, people leadership, talent development

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