A global medical devices company in Caesarea is looking for a Quality Engineer, Equipment Validations,
• Quality Management System (QMS) team member, subordinate to QMS Manager.
• Develop validations for equipment and software per ISO 13485/FDA 21 CFR part 820.
• Generate and review documents such as: drawings, SOPs, equipment and software validation, protocols and reports.
• May perform or lead QMS or Design Assurance activities (e.g., document control, audits, nonconforming product, ECO).
• B.Sc. in Mechanical/Electrical/Biomedical Engineering.
• At least 3 years of experience in validation activities in the medical device field.
• Quality Management System experience.
• Familiar with QMS investigation tools (fishbone, 5 whys, etc.).
• Proficient in English and technical writing.
• Highly developed understanding of technical equipment.
• Willingness to travel abroad up to twice a year.
• Great interpersonal skills.
• Organized and meticulous, detailed-oriented.
• Strong problem-solving and critical thinking skills.
• Both a team player and able to work independently with solid prioritization capabilities.