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 verification and validation (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 V&V – rigorous testing, data analysis and reporting – we ensure regulatory compliance and support successful submission to authorities.

These numbers demonstrate that quality is built through the discipline and dedication of Quality Engineering professionals.

Responsibilities of Scientists 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—every step is handled with precision and scientific integrity.

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 by creating SOPs, work instructions, tools and methodologies that help teams work efficiently and consistently.

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

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 but 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, helping other teams understand not only what needs to be done, but why it matters.

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 a rule to follow – it's a mindset, a shared value, and a source of pride.