Quality Systems Associate

Quality Systems Associate

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've 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."

Why join Diasorin?

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!

Job Scope

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

Job Tasks and Responsibilities

• Coordinate documentation review and approval cycles through the SmartSolve Document Module
• Ensure good documentation practices are followed across various departments within DiaSorin 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.
• Coordinate documentation translation.
• 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

Education, Experience and Qualifications

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