דרושים Quality Engineer ביקנעם

Microbot Medical is a cutting-edge medical device endovascular robotic surgery company, seeking an experienced, motivated Quality Engineer to join our team.

We are on a mission to redefine endovascular procedures with the LIBERTY® Endovascular Robotic System, a remote, single-use and fully disposable robotic system for endovascular procedures. Across the three spaces of the endovascular market which includes peripheral, coronary and neurovascular, it is one of the largest markets with clear unmet needs, but still with minimal penetration of robotics. LIBERTY is designed to redefine the endovascular surgical robotics marketplace by overcoming many obstacles that hinder the adoption of other robotic systems by eliminating the large capital footprint and its expense, and creating a system that is easy to use, requires short learning curve, and has the potential to add value for all stakeholders.

Objective:

Microbot is seeking an experienced Quality Engineer. The successful candidate will join a dynamic company and will report to the VP of RA/QA.

The candidate will support QA and Production activities to ensure Quality Management System compliance with ISO 13485, QMSR, MDR.

Main Responsibilities:

Primary Responsibilities in Production

• Monitor in-process quality controls and production line inspections, including incoming, in-process and finish goods quality controls.
• Monitor production-related non-conformities and corrective actions
• Review production documentation (DHRs) for accuracy and compliance
• Oversee production manufacturing activities (including production in cleanroom)
• Oversee acceptance, performance and routine maintenance of equipment calibration and maintenance activities

Additional QA Support

• Support quality records and activities follow-up, including CAPAs and MRB/NCR
• Support supplier qualification and evaluation
• Support training/qualification and competency activities with follow-up
• Assist with internal and external audits
• Manage document control activities
• Provide QA support to other departments/employees

Education and Experience

• Bachelor’s degree in science or engineering (Mechanical, Biomedical, or related)
• Minimum 3 years' experience as quality engineer/QC activities in medical device industry (ISO 13485, FDA QMSR, MDR)

Skills

• Strong communication and teamwork abilities
• Excellent technical comprehension
• Proficient in English (reading and writing)
• Proficient in standard MS Office applications