Senior Design Quality Assurance Expert (100% remote)

We are looking for a Senior Design Quality Assurance Expert for one of our clients in the Digital Health / Life Sciences Sector.

Bachelor’s or Master’s degree in Science, Software Engineering, Biomedical Engineering, or a related discipline.

• +5 years of professional experience in Quality Assurance within regulated environments (Medical Devices, IVD, Pharma, Digital Health).
• Strong expertise in software quality engineering and design controls across the full product lifecycle.
• Proven experience applying risk management methodologies (ISO 14971) and design control processes.
• Solid knowledge of global regulatory standards and frameworks, including:
• FDA QSR
• ISO 13485
• ISO 14971
• IEC 62304, IEC 82304, IEC 62366
• Relevant cybersecurity standards
• Experience supporting documentation management systems, change control, product release processes, ...