Quality Engineer

Quality Engineer – R&D | Medical Devices

A leading and stable medical device company, known for its innovation and high engineering standards, is seeking a Quality Engineer to join the R&D department. This role is critical in ensuring that quality is embedded throughout the product development lifecycle.

Location: Bar-Lev Industrial Park, Northern Israel

Responsibilities:

• Ensure compliance with global regulatory requirements and quality standards, including FDA QSR, ISO 13485, and EU MDR
• Participate in design control activities and lead risk management processes (e.g., FMEA)
• Support process validation and verification activities for both design and manufacturing processes
• Maintain accurate and comprehensive quality documentation throughout the product lifecycle
• Collaborate cross-functionally with R&D, manufacturing, regulatory affairs, and quality assurance teams
• Provide training and support on quality-related topics across the organization
• Stay current with regulatory changes, quality trends, and best practices in the medical device industry

Requirements:

• B.Sc. in Engineering, Quality, or a related field
• 3–5 years of experience in quality engineering within the medical device industry
• Strong knowledge of medical device regulatory requirements (FDA QSR, ISO 13485, EU MDR)
• Experience with design control, risk management, and validation methodologies
• Excellent analytical, communication, and project management skills
• Fluent in English and Hebrew (written and verbal)
• CQE (Certified Quality Engineer) – an advantage

Personal Attributes:

• Detail-oriented and methodical
• Proactive, with strong problem-solving abilities
• Able to work independently and manage multiple priorities
• Passionate about improving patient outcomes through quality excellence