Quality Engineer – Development & Regulatory

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Karmiel, North District, Israel

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Trevo

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Job Description

About the role

A global, stable, and technologically advanced medical device company is looking for a Quality Engineer – Development & Regulatory to join its team. Location: Bar-Lev Industrial Park Work Model: On-site, with the option for hybrid work – up to 2 days from home per week. The position focuses on regulatory affairs, product registration and documentation, alongside active involvement in quality and product development processes throughout the product lifecycle.

What you'll do

Lead regulatory registration and documentation processes for medical devices.
Prepare regulatory documents, protocols, reports, and technical documentation.
Support new product development processes from concept through transfer to production.
Participate in Design Reviews and Design Control activities throughout the product lifecycle.

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Ensure compliance with ISO 13485, FDA, and MDR/CE requirements.

Prepare, update, and maintain product files and engineering/regulatory documentation.

Support engineering change processes, regulatory updates, and regulatory events.

Lead CAPA processes, non-conformance investigations, and Root Cause Analysis.

Work closely with R&D, Engineering, Quality, Regulatory Affairs, and Manufacturing teams.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Quality, or a relevant field.
2+ years of experience in Quality and Regulatory Affairs within the medical device industry – mandatory.
Significant experience in writing, preparing, and managing regulatory documents and protocols – mandatory.
Strong knowledge of ISO 13485, FDA, and MDR/CE requirements.
Very high level of English – reading, writing, and speaking.
Strong analytical skills, attention to detail, and excellent organizational abilities.
Ability to work effectively with multiple interfaces and manage several tasks simultaneously.

Nice to have

Experience working in medical device product development – a significant
Experience with CAPA, risk analysis, and failure investigations – an

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About the role

What you'll do

Requirements

Nice to have