Medical Device QA Manager

Position Overview

CustoMED is seeking a QA Engineer to support quality assurance activities across software development and physical product design. The role operates at the intersection of two teams -software and the PSI design laboratory -and requires the ability to function effectively in both environments. The position reports directly to the RA/QA Lead and is integral to maintaining CustoMED's ISO 13485-certified quality management system and supporting regulatory compliance across all product lines.

Key Responsibilities

Quality Management System

• Maintain and execute QMS procedures in accordance with ISO 13485 and applicable regulatory requirements.
• Support CAPA processes: initiation, investigation, root cause analysis, and effectiveness verification
• Manage nonconformance records and deviation reports
• Assist in preparation and execution of internal audits
• Maintain controlled documents and support document change control procedures in Monday.com

Software QA

• Collaborate with the software team to execute verification and validation activities in accordance with IEC 62304
• Review and maintain software test plans, test cases, and test reports
• Participate in software risk management activities per ISO 14971
• Track and document software anomalies; support anomaly log maintenance
• Support regression testing and change control review for software releases

Lab / Physical Product QA

• Work with the PSI design laboratory to support design verification activities for patient-specific instruments
• Review and maintain design output verification checklists and manufacturing records
• Support supplier qualification and incoming inspection processes
• Assist in the preparation and maintenance of the Design History File (DHF) documentation
• Participate in sterilization, biocompatibility, shelf life, and packaging validation activities as required

Regulatory Support

• Support preparation of technical documentation for FDA 510(k) and EU MDR submissions
• Assist the RA/QA Lead with Pre-Submission (Q-Sub) and 510(k) documentation tasks
• Maintain traceability matrices and risk management files
• Support design control documentation throughout the product development lifecycle

Requirements

Education

• B.Sc. in Biomedical Engineering, Industrial Engineering, Life Sciences, or equivalent

Experience

• 4-6 years of hands-on QA experience in a medical device company
• Direct experience working within an ISO 13485-certified QMS
• Experience supporting both software and hardware/physical device development - a strong advantage

Knowledge & Skills

• Working knowledge of ISO 13485, ISO 14971, and IEC 62304
• Familiarity with FDA 21 CFR Part 820 / QMSR -advantage
• Experience with document control and task management systems; Monday.com -advantage
• Ability to write and review technical documentation clearly and precisely
• Strong attention to detail with the ability to manage multiple concurrent tasks
• Comfortable operating in a lean, fast-moving startup environment

Languages

• English -fluent written and spoken (required; all QMS documentation is in English)
• Hebrew -native or fluent