Quality Systems Associate

Quality Systems Associate

Published on:
Sep 8, 2025

Country:
United States

Job Category:
Quality

Employment type:

Regular Full Time

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we have earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Impactful Work:
When you join Diasorin, you become part of a team that’s dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

Global Reach & Innovation:
Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture:
We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team:
If you’re passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We’re looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that’s shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

This position is responsible for overseeing, monitoring and enhancing the existing Dia Sorin documentation system as well as performing final review and approval of device history records.

• Coordinate documentation review and approval cycles through the Smart Solve Document Module
• Ensure good documentation practices are followed across various departments within Dia Sorin Inc.
• Prepare and support rapid and deadline driven document delivery for Quality, Compliance and Regulatory inspections as assigned.
• Review and provide guidance on record completion and approve final manufacturing lot documentation.
• Review document change plans to assure compliance with QMS requirements.
• Review for format and prepare release versions of product labeling (IFU, MSDS, Labels).
• Upload and confirm customer facing device labeling (IFU, MSDS) on web portal.
• Create and maintain part information (bills of material, routings, part numbers etc.) in SAP.
• Provide training and guidance to the organization related to quality system documentation practices.
• Design and develop processes to implement and improve the QMS.
• Maintains and troubleshoots processes and procedures. Helps define QMS requirements
• Maintain records and archive as required per requirements

• Associate s Degree in Quality, Technical Documentation, Data Analysis or equivalent or equivalent experience required
• Minimum 1+ Years in related field or demonstrated documentation system competence within a cGMP corporate environment required
• Minimum 1+ Years of related documentation system experience within regulated environment required
• Experience using Microsoft Office (MS Word, Excel, PowerPoint) and SharePoint/Teams required
• Service oriented mentality and a strong focus on customer needs
• Strong independent / cross-disciplinary skills
• Ability to work independently with minimal supervision as well as with a team
• Ability to work in a regulated environment
• Ability to train team members on basic group procedures and tasks
• Effective process management and analytical skills

The hiring range for this position is $24.30 - $29.70…