Job Scope

This role serves as the subject matter expert and go-to authority regarding the Diasorin Inc. Calibration Program. Calibration Program Lead to oversee 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.

Duties and Responsibilites

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 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.

Quality Assurance:

• Oversee the calibration, maintenance, and repair of equipment and instruments
• Ensure investigations for out-of-tolerance events by coordinating with the equipment owner and implement corrective and preventive actions when required for the calibration/maintenance program
• Act as the subject matter expert in the SmartSolve 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.

Continuous Improvement:

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

Regulatory Compliance:

• 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

Education, Experience and Qualifications
• Bachelor's Degree in related industry is preferred
• 5+ years of Calibration program related experience in the IVD (In Vitro Device) or other medical device industry is preferred
• Problem-solving and decision making skills
• Ability to analyze technical data
• Computer skills and software knowledge - MS Word, Excel and PPT. Familiarity with Google Suite, Pilgrim (SmartSolve) and SAP software.

What we offer

The hiring range for this position is $ XX -$ XX annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.