Quality Engineer
4 days ago
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
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