QA/QC Manager (On Site - Israel)

Company Overview

Dosentrx is transforming how oral drug therapies are delivered and monitored. Our cleared, software‑integrated medical device is already improving patient outcomes, with adoption growing rapidly year over year. As we scale, we’re looking for a quality leader who thrives in a fast‑paced, hands‑on environment and is motivated by building systems that ensure safety, reliability, and regulatory excellence.

Role Summary

We are seeking a proactive, detail-oriented QA/QC Manager to lead quality activities for our commercialized medical device.

This role will contribute to the development and scaling of the Quality Management System (QMS), ensure compliance with ISO 13485 and FDA QMSR (21 CFR 820), drive design and development quality, oversee supplier and manufacturing quality, and support future regulatory submissions.

The ideal candidate is comfortable translating regulatory requirements into practical, scalable processes

Responsibilities

• Own, maintain, and improve the QMS in compliance with ISO 13485 and FDA QMSR (21 CFR 820).

• Lead design controls, design reviews, and DHF/DMR documentation throughout the development lifecycle.

• Manage risk management activities per ISO 14971 and oversee IEC 62304 software lifecycle quality processes.

• Approve and oversee V&V planning and execution for hardware and software. • Lead CAPA, complaints, nonconformance handling, and internal audit activities.

• Oversee supplier quality, including qualification, quality agreements, IQC/OQC, vendor audits, and MRB.

• Support manufacturing quality, including process validation and production controls.

• Map, define, and improve quality processes to support scalability and compliance

• Partner cross‑functionally with Engineering, Product, and Operations to ensure compliance across the product lifecycle.

Requirements

• A bachelor’s degree in engineering, exact sciences, or a related field.

• 5+ years of QA/QC experience in the medical device industry.

• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and IEC 62304; relevant certifications (e.g. Lead Auditor, CQE) a plus.

• Proven experience with design controls, risk management, design reviews, CAPA, and supplier quality processes.

• Highly organized, detail-oriented, and able to manage multiple priorities.

• Strong communication skills in English and Hebrew.

• High integrity, strong interpersonal skills, and a proactive, solution-oriented approach.

• Comfortable working in a fast-paced startup environment, with a strong ability to collaborate across teams and drive execution. 

This position is open to candidates of all genders.

Please send your CV, cover letter and salary requirements to: [email protected]