Required Quality & Regulatory Compliance (Q&R) Leader.
For a startup developing breakthrough medical technologies, with offices in the Haifa area.
To oversee and perform of all routine QA activities (CAPA, complaint handling and vigilance, document control, risk management, failure investigation, purchasing controls, etc.) to ensure compliance with regulatory and company procedure requirements, including:
Preparing audits and participating in internal and external audits. Leading quality initiatives with Operations (Production, Engineering, Suppliers) to improve manufacturing processes and product quality. Preparing management reviews of our quality system.
Compiling and maintaining technical and design history files.
Overseeing design controls from user needs to mass production. Interfacing with Operations, R&D (Hardware, Software) and clinical teams.
Reporting to our VP in charge of regulatory compliance and quality.
Requirements:
B.Sc. in engineering / Certified Quality Engineer (CQE).
5 years experience as a QA engineer for a medical device company.
Familiar with medical standards ISO 13485, MDSAP, MDD/MDR, 21CFR 820, ISO 14971.
Familiar with device standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 and usability standards.
Experience in leading external and internal audits; Certified auditor - an advantage.
Familiar with Arena / Priority / some other ERP/PLM control system - an advantage.
Excellent Hebrew and English.
Strong attention to detail and accuracy.
Well organized with an understanding of priorities and changing demands.
Able to travel from time-to-time to suppliers in Israel and abroad.