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Join our team
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Join Our Team

Quality Engineer, Class III Medical Devices

Description

Biosense Webster, Inc., part of the Johnson & Johnson Family of Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies to improve the quality of care for arrhythmia patients worldwide.

We are looking for a Quality Engineer to join our talented team and support product development processes!

Responsibilities:
• Supports Product Development process compliance; verify that product is being tested per applicable standards and essential requirements are met, and product is properly being transferred to manufacturing and initiate product improvements
• Supports Risk Management methodology and problem investigation
• Reviews Defect Meetings and Clinical Readiness Results and escalate potential Regulatory/Safety
• Supports design controls of class III devices, including Design History File management of the products
• Supports Quality activities during product development, including design changes and assessment and transfer from R&D to production
• Supports and implements quality processes and standards for new product introduction (including internal Johnson & Johnson standards and processes)
• Supports Non-conformances, Corrective and Preventative Actions, Audits, Training and Quality System activities as needed and ensures compliance to all applicable due dates
• Serves as Extended Team Member on Product Development Projects; Leads Quality activities for tools and jigs development

Requirements

• Bachelor’s Degree in Engineering or related science field
• 3 years of related QA work experience
• New product development experience from medical device industry or other highly regulated field
• Ability to travel up to 10% domestic and international
• Good English skills (write\speak)
• Big picture orientation with attention to detail

Location: יקנעם

Comments

Biosense Webster is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.