Quality Assurance Associate

Responsibilities:

· 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.

· Strong computer skills.