Quality Assurance Associate

Collaborate with cross-functional teams to ensure quality

standards throughout the product lifecycle.

Support QA activities related to product development,

manufacturing transfers, and ongoing operational processes.

Manage and control Quality Management System (QMS)

processes, including deviations, CAPA, complaints, changes, and training.

Maintain a comprehensive understanding of quality and

regulatory requirements, with a focus on ISO 13485 compliance.

Demonstrate meticulous attention to detail in all QA-related

tasks.

Work effectively under pressure to meet quality and project

deadlines.

Exhibit assertiveness and strong teamwork skills to drive

quality initiatives.

Requirements:

2-5 years of relevant experience in a QA position within the

medical device industry.

First degree in a relevant science or engineering subject.

Proficiency in managing and controlling QMS processes,

including deviations, CAPA, complaints, changes, and training.

Thorough understanding of GMP and GDP requirements.

Familiarity with technical drawings and specifications.

High-level proficiency in English, both written and spoken.

Excellent writing skills in English and Hebrew, including

the ability to create specifications for quality control, MRB, SOPs, and

quality records.

Experience in design control and Design History File (DHF)

is an advantage.

Familiarity with manual or automated quality systems is

advantageous.