Quality Engineer

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