Scientists are often associated with test tubes, microscopes, and white coats – yet their impact goes far beyond the laboratory. Every day, our scientists work behind the scenes to ensure the highest quality standards across everything we do.

Quality Engineering at Sysmex Partec

At Sysmex Partec, quality isn't an afterthought – it's built into every stage of the product lifecycle, from initial concept and design through development and production.

Our Quality Engineering team ensures that every medical diagnostic product meets the highest standards of performance, reliability, and compliance. Specialized in design controls, development documentation, risk management, and usability engineering, we ensure that every step of the process is carefully managed.

Our comprehensive V&V studies are supported by clear and thorough test documentation. The result? Medical diagnostic products that not only meet regulatory standards – but also deliver confidence to users and stakeholders.

Managing DHFs for Success

For Quality Engineering scientists, the Design History File (DHF) is at the center of their work – a detailed record that tracks every stage of product development, from planning and specifications to production transfer and change management.

By maintaining DHFs and driving rigorous testing, data analysis and reporting, we ensure regulatory compliance and support successful submission to authorities.

Responsibilities in Test Documentation

Our Quality Engineering scientists invest significant effort in planning, executing, and documenting both literature-based inspection tests and experimental bench tests – from carefully reviewing applicable guidelines and standards to designing robust test plans, preparing statistical analyses, and generating clear, compliant reports.

A single DHF can include dozens of documented studies and hundreds of approved reports – reflecting the depth of analysis and commitment required to meet regulatory expectations such as IVDR.

The Role of a Quality Engineering Specialist

A key responsibility of the Quality Engineering specialist is the development, maintenance, and continuous improvement of development processes – creating SOPs, work instructions, tools, and methodologies that help teams work efficiently and consistently.

With a strong focus on risk management, our Quality Engineering specialists identify and mitigate potential issues early across the entire product lifecycle, from design through manufacturing and usability. By collaborating closely with development, production, and regulatory teams, they enable innovation and product changes while ensuring full compliance.

Quality Through Communication and Collaboration

A critical skill of the Quality Engineering team is effective communication. Our scientists not only interpret and analyse complex scientific data – they also translate it into clear, actionable guidance for operators, engineers, managers, and auditors. We don't just present data. We explain the "why" behind every requirement.

Collaboration is just as essential. Quality Engineering scientists act as a bridge between development, manufacturing, quality assurance, and regulatory teams – often connecting colleagues across the globe. Through these connections, we foster a culture where quality is more than compliance. It's a shared commitment.