Join our medical device team as an Operations Quality Engineer! You'll be a key QA RA representative, ensuring product quality and regulatory compliance throughout the manufacturing process, from design transfer to shipment. Drive continuous improvement, optimize processes, and champion quality on the production floor.
Responsibilities:
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).
Requirements: 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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