Calibration Program Lead

DiaSorin; Minnesota; On-site; USD 66,400 - 98,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive program

Job summary

Diasorin seeks a Diagnostics Calibration Program Lead for its U.S. In Vitro Diagnostic manufacturing facility. You will own the calibration strategy, manage daily operations, and ensure ISO, GMP, FDA/IVDR compliance while coordinating with asset owners and suppliers.

This senior role requires 5+ years in calibration within IVD or medical devices, plus strong data analysis and problem-solving abilities. Proficiency with Pilgrim/SmartSolve and SAP is preferred.

Qualifications

• Bachelor's degree required.
• 5+ years calibration program experience in IVD or medical devices preferred.
• Strong problem-solving and data analysis skills.
• Familiarity with Pilgrim (SmartSolve) and SAP software.

Responsibilities

• Lead calibration strategy aligned with regulatory requirements.
• Direct day-to-day calibration program operations and asset management.
• Develop and maintain calibration procedures in line with ISO, GMP, and IVD regulations.
• Generate trends for on-time and past-due maintenance; report quality data.
• Serve as site administrator for asset software and train teams as needed.

Skills

Calibration Mgmt

Regulatory compliance

Data analysis

MS Excel

Education

Bachelor's degree

Tools

Pilgrim SmartSolve

SAP

Google Suite

MS Office

Job description

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.

Why Join Diasorin

• 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.

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 Responsibilities

• 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.
• 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

Other Responsibilities

• 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 a related industry is preferred
• 5+ years of Calibration program related experience in the IVD 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 $66,400 - $98,000 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 well‑being, 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.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.