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 weve 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 thats 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 youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were 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 thats 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

• Associates 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
• Good communication skills
• 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 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 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 or protected veteran status and will not be discriminated against on the basis of disability.

In compliance with federal law all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process please contact the North America Talent Acquisition Team at or 1- to request an accommodation.

The above job description is intended to describe the general content identify the essential functions and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.