Medical QA/RA
- ישראל
- משרה קבועה
- משרה מלאה
- Lead QA/RA activities in manufacturing, purchasing, and warehousing.
- Maintain compliance with ISO 13485 and FDA regulations.
- Review and approve operational documents (procedures, ECOs, etc.).
- Facilitate Material Review Board (MRB) meetings.
- Implement and monitor process controls (PV, EQ, pFMEA).
- Support process validation activities (IQ/OQ/PQ).
- Monitor KPIs, collect data, and report on operational performance.
- Support CAPA investigations and external audits.
- Manage supplier quality aspects (SCARs, audits).
- Liaise between R&D and Operations for smooth transitions.
- Bachelor's degree in science, engineering, or a related technical field, required.
- Minimum 5 years of Operations Quality experience in the medical device industry.
- Strong knowledge of ISO 13485 and FDA regulations.
- Excellent English communication skills.
- Proven ability to coordinate, prioritize, and resolve complex problems.
- Experience with process validation, cleanroom controls, and supplier quality management.
- Knowledge of Lean Manufacturing, 6S, and SPC.
- CQE certification is a plus.
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