Calibration Engineer

Nova Med GMBH

GENERAL TASKS:

• Perform and monitor calibration process of the Plant according to ISO 13485, FDA 21 CFR 820, ISO 17025, and other international standards,
• Be a point of contact for temperature and pressure calibration processes,
• Establish and maintain local procedures/ instructions/ forms related with the plant calibration process,
• Develop and maintain calibration programs for new and existing products,
• Ensure calibration methods training activities for the technicians,
• Establish, develop, and report KPI activities of calibration processes,
• Take an active role in the activities conducted with the external calibration laboratories and act as a go-between with the Plant and the laboratories,
• Support NC/CAPA processes,
• Participate actively in audits and provide inputs on calibration processes,
• Assist in the development and implementation of quality improvement initiatives,
• Work with cross-functional teams to resolve issues and ensure product quality.

YOUR PROFILE:

• Bachelor’s Degree from Engineering Departments,
• Excellent command of English both oral and written,
• Minimum 3 years of experience in calibrations processes, electronic and mechanical equipment’s,
• Experience and knowledge of ISO 13485, FDA 21 CFR 820, ISO 17025, and ISO 9001 standards, understanding the medical device regulatory requirements,
• Preferably having experience in medical industry facilities OR good knowledge and experience in calibrating measuring instruments in accredited laboratories,
• Ability to use software and hardware tools for calibrating and adjusting, proficient in MS Office Programs,
• Very good knowledge of measurement uncertainty calculation and evaluation,
• Good interpersonal and communication skills, eager to work as a team member,
• Willingness to follow and implement industry changes and developments,
• Having problem solving skills with analytic approach.