Calibration Program Lead

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

• Build What Matters – Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale – Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture – Thrive in a culture that values accountability, inclusion, and continuous development.

This role serves as the subject matter expert and go-to authority regarding the Diasorin Inc. Calibration Program. The Calibration Program Lead oversees all aspects of the calibration program within our In Vitro Diagnostic (IVD) manufacturing facility, ensuring compliance with IVD regulations while maintaining the accuracy and reliability of our measurement and test equipment.

Maintain a comprehensive calibration strategy aligned with IVD regulatory requirements.

• Lead the day-to-day operations of the calibration program, including external supplier scheduling, notification of required actions for internal asset owners, and maintenance of the asset management system to ensure updated and current tracking of equipment.
• Establish and maintain calibration procedures, ensuring compliance with applicable ISO standards, Good Manufacturing Practices (GMP), and IVD regulations.
• Generate trending data of on-time and past-due preventative maintenance and calibrations. Communicate and report quality performance data. Provide input into preventative action plans in setting goals and alignment metrics to business strategies.
• Act as site administrator for equipment/asset software and provide guidance and/or training for other areas, as needed.

• Oversee the calibration, maintenance, and repair of equipment and instruments.
• Ensure investigations for out-of-tolerance events by coordinating with the equipment owner and implementing corrective and preventive actions when required for the calibration/maintenance program.
• Act as the subject matter expert in the Smart Solve QMS System related to equipment/assets, performing change plan reviews and approvals for plans associated with asset acquisition, installation, and repair activities. Support equipment owners with change plans as required to document activities related to asset acquisition, installation, and repair activities. Initiate and own change plans as related to updates and revisions to calibration/maintenance programs and equipment under calibration ownership.
• Create non-conformance records as required and act as the calibration representative where needed for equipment-related non-conformance records.

• Identify and implement innovative technologies and best practices in calibration.
• Analyze calibration data and metrics to drive program improvements.

• Ensure continued compliance with IVD regulations, including EU IVDR and US FDA requirements.
• Act as the subject matter expert during regulatory inspections and audits.
• Maintain accurate calibration records and documentation for regulatory purposes.

• Perform other functions as required.
• Work and communicate effectively with a wide range of co-workers in a cooperative manner.

• Bachelor's Degree in a related industry is preferred.
• 5+…