Quality Engineer, Equipment Validations

02/02/2022

תיאור

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.