Quality Assurance Assistant

AquaPass is an innovative Medical Device startup, located at Hutzot Shefayim, that design and manufacture system that enables excess fluid removal through the skin.

We are seeking a part-time (50% - 80%) proactive and detail-oriented QA Assistant to support the QA Manager with daily QA activities in compliance with ISO 13485 and FDA 21 CFR 820 requirements.

Key Responsibilities

• Collaborate with cross-functional teams to ensure compliance with internal procedures and regulatory requirements.

• Lead activities and actions items from QMS processes (e.g., Design Control, ECO, CAPA, NCI processes).
• Assist and support in routine QA assignments according to company QMS procedures.
• Preparation, logging, and filing of controlled documents and records.
• Support quality-operation activities such as suppliers' evaluation, purchasing, inspections, MMEs calibration and maintenance, production activities (at subcontractors), etc.
• Support preparation for audits and management review meetings.
• Monitor regulatory developments (e.g., FDA QSMR, ISO 13485) and perform gap analyses.

REQUIRED BACKGROUND & EXPERIENCE

• 3+ years of experience in Quality Assurance or Quality Control within the medical industry.
• Bachelor's degree in Life Sciences, Engineering, or related field.
• Proficient in MS Office (Word, Excel, PowerPoint).

ADVENTAGES

• Experience working under a Quality Management System (QMS) in the medical device sector
• Knowledge of ISO 13485, EU MDR (2017/745), and/or FDA 21 CFR Part 820.

We are looking for:

• Strong organizational and documentation skills.
• Excellent attention to detail with the ability to manage multiple priorities
• Good written and verbal communication skills in English
• Willingness to travel to subcontractors when needed (e.g., Tiberias).

Send CVs to: [email protected]