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Quality Engineer
Quality EngineerDiaSorin • Stillwater, MN, US
Quality Engineer

Quality Engineer

DiaSorin • Stillwater, MN, US
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Overview

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Quality Engineer

Published on : Sep 27, 2025

Country : United States

Job Category : Operations

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 a reputation for excellence by developing innovative diagnostic assays and instruments trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions positions us as the Diagnostics Specialist.

Why Join Diasorin? We offer impactful work, global reach and innovation, and a diverse and inclusive culture. Join our team to contribute to patient care and global healthcare solutions, collaborate with colleagues worldwide, and thrive in a supportive environment.

Responsibilities

  • As a Quality Engineer, act as an administrator and Quality Management System (QMS) expert for equipment used in the manufacture of in-vitro diagnostic products.
  • Drive operational improvement activities involving equipment procurement, validation, or transfer of information from equipment.
  • Be a QMS record owner, collaborate with Subject Matter Experts (SME) for equipment and validations, and implement changes to business systems and processes.
  • Interact with teams across Diasorin to provide centralized support.
  • Generate equipment specifications and user requirements with SMEs, identify suppliers, and participate in procurement activities including supplier approval, expense planning, facility planning, equipment validation, and user training.
  • Drive change plans and validations for new and existing equipment in reagent manufacturing, coating, and QC laboratories.
  • Coordinate and document equipment troubleshooting activities.
  • Report progress on tasks and initiatives to management, and share knowledge with co-workers and new employees.
  • Manage equipment user manuals in electronic systems.
  • Perform complex testing activities to support equipment use in manufacturing laboratories; construct, troubleshoot, calibrate, validate, adjust, test, diagnose, and maintain equipment and systems; prepare compounds and solutions as needed.
  • Operate with minimum supervision in laboratory, production, and test environments according to scheduled due dates.
  • Create and modify maintenance procedures, determine preventive maintenance, safety, and lockout / tagout requirements from manuals and process requirements.
  • Document maintenance actions in an equipment tracking database in compliance with regulatory requirements.
  • Adhere to safety, disposal, and gowning requirements as required.

Education, Experience and Qualifications

  • Knowledge of IVD technology and judgment in determining work methods and data recording.
  • Minimum of 5 years of relevant experience; may require vocational or technical education or advanced certification in addition to prior work experience.
  • High school diploma and associate degree with 6 years of experience in a regulated manufacturing or development laboratory, or a BS in Engineering with 1-2 years of experience.
  • Understanding and experience with compliance to ISO, FDA, and other regulatory agencies, as well as quality process management and implementation.
  • Experience using Microsoft Office products; strong technical ability, equipment setup, and troubleshooting skills.
  • Excellent writing and documentation skills for maintenance and validation activities.
  • Understanding of process improvement, instruction document routing development, standard manufacturing practices, and workmanship / quality standards.
  • Good organizational and verbal communication skills; ability to work across electronic, mechanical, and electromechanical equipment;
  • Experience working from schematics, engineering drawings and written or verbal instructions; ability to understand cultural differences and collaborate effectively.
  • What we offer

    Salary Range

    The salary range for this position is $70K - 84K. Beyond base salary, Diasorin offers a comprehensive benefits package focused on well-being, including health benefits, retirement and financial well-being, time off, wellbeing support, and other perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may be eligible to participate in an annual incentive program.

    Equal Opportunity

    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, protected veteran status, or disability status.

    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 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. Offers of employment 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 without expressed, written consent from the Diasorin Human Resources Department.

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    Quality Engineer • Stillwater, MN, US