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Diasorin · 1 month ago

Quality Systems Associate

Stillwater, MN

Full-time

Onsite

Entry Level

$24.30/hr - $29.70/hr

1+ years exp

Diasorin is a global leader in diagnostic solutions, dedicated to improving lives through innovative healthcare tools. The Quality Systems Associate role involves overseeing and enhancing the documentation system and ensuring compliance with quality management standards.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

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

Qualification

Quality Management System (QMS)SAPDocumentation system competenceMicrosoft OfficeService oriented mentalityIndependent skillsEffective process managementAnalytical skillsCommunication skillsTeam collaboration

Required

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

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

Benefits

A competitive rewards package focused on your overall well-being

A comprehensive plan of health benefits

Retirement and financial wellbeing

Time off programs

Wellbeing support and perks

Annual incentive program

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (1)

2022 (1)