Quality Assurance:

Oversee the calibration, maintenance, and repair of equipment and instruments\nEnsure 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\nAct 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.\nCreate 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\nAnalyze calibration data and metrics to drive program improvements

Regulatory Compliance:

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

Perform other functions as required.\n
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\n
5+ years of Calibration program related experience in the IVD (In Vitro Device) or other medical device industry is preferred\n
Problem-solving and decision making skills\n
Ability to analyze technical data\n
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 $31.92-$47.11 hourly. 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. 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. Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact hr@diasorin.com. Recruitment Fraud Notice Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact hr@diasorin.com for verification. 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