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The Calibration Engineer is responsible for performing, maintaining, and documenting internal calibrations of manufacturing, laboratory, and test equipment within a regulated medical device environment. This role ensures the accuracy and compliance of measuring instruments, including dimensional/measuring devices, temperature-related equipment, force and load measurement systems, and other critical calibration assets. The Calibration Engineer supports quality and regulatory requirements by executing calibration activities in accordance with internal procedures, applicable standards (e.g., ISO 13485, ISO 17025), and regulatory expectations, while contributing to continuous improvement and audit readiness.
Job Responsibility:
Perform internal calibration of manufacturing, laboratory, and inspection equipment, including dimensional/measuring devices, temperature systems (ovens, chambers, sensors), force and load measurement equipment, and other test instruments
Develop, execute, and maintain calibration procedures, work instructions, and schedules in accordance with ISO 13485, ISO 17025, and applicable regulatory requirements
Ensure calibration activities are traceable to national and international standards and maintain accurate calibration records and certificates
Evaluate calibration results, identify out-of-tolerance conditions, initiate corrective actions, and support root cause investigations as required
Manage calibration status of equipment, including labelling, tracking, and control of calibrated and non-calibrated assets
Support audits and inspections by providing calibration documentation and technical expertise to internal, customer, and regulatory auditors
Collaborate with Quality, Engineering, Manufacturing, and Validation teams to support equipment qualification and process control
Coordinate with external calibration service providers when required and review third-party calibration reports for compliance
Participate in continuous improvement initiatives to enhance calibration methods, accuracy, efficiency, and compliance
Ensure compliance with safety, quality system, and documentation requirements in all calibration activities
Requirements:
Formal training in calibration principles and measurement systems
Training or working knowledge of quality systems and regulatory standards applicable to medical devices (e.g., ISO 13485, ISO 17025)
Previous experience performing calibration activities in a regulated industry, preferably medical devices, pharmaceuticals, or aerospace
Hands-on experience with calibration of dimensional/measuring instruments, temperature-controlled equipment, and force or load measurement systems
Experience managing calibration records, certificates, and equipment status within an electronic or manual calibration system
Proficiency in calibrating a wide range of equipment, including gauges, micrometers, calipers, temperature sensors, chambers, force gauges, and load cells
Competence in data analysis, documentation, and technical report writing
High level of attention to detail and commitment to accuracy
Strong analytical and problem-solving skills
Methodical, organized, and disciplined approach to work
Ability to work independently while also collaborating effectively within cross-functional teams
Strong sense of ownership, accountability, and quality mindset
Ability to work in laboratory, manufacturing, and cleanroom environments as required
Willingness to occasionally support off-shift or weekend activities to meet operational needs
Ability to handle precision instruments and calibration equipment safely
Compliance with company policies, quality system requirements, and safety procedures
Physical ability to lift and transport calibration equipment within defined safety limits
Nice to have:
Health and safety training relevant to laboratory and manufacturing environments
Experience supporting internal, customer, or regulatory audits is preferred
Experience working with external calibration service providers is desirable