Calibration Program Lead

Diasorin • Stillwater, MN

2d

About The Position

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

Requirements

• 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.

Nice To Haves

• 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

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.
• 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
• 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

Benefits

• health benefits
• retirement and financial wellbeing
• time off programs
• wellbeing support and perks
• annual incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level