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.

SKILLS 🤹:

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

• Experience:

  • +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, and complaint handling.

  • Hands-on experience participating in audits, inspections, design reviews, and milestone reviews as a subject matter expert.

  • Practical experience working in agile development environments (Scrum, Kanban).

  • Strong technical understanding of software development lifecycles, systems engineering, and associated toolchains.

• Fluency in English, with ability to communicate precisely and confidently in complex technical and regulatory discussions

TASKS & RESPONSIBILITIES 🚀:

1. Design Quality Leadership

Provides strategic quality leadership within cross-functional teams, ensuring digital health products comply with global regulatory requirements throughout the development lifecycle.

2. Regulatory Compliance & Standards Application

Applies design controls, risk management, and quality standards (FDA QSR, ISO, IEC) to ensure compliant, high-quality software and system solutions.

3. Cross-Functional Collaboration
Acts as a key bridge between software development, product management, regulatory, and quality teams, fostering alignment and efficient delivery.

4. Documentation & Quality System Support
Supports document management, change control, product release activities, and complaint handling processes in accordance with quality management system requirements.

5. Audit & Inspection Support
Serves as a subject matter expert during audits, inspections, design reviews, and milestone reviews, ensuring readiness and regulatory alignment.

6. Risk Management & Problem Solving
Identifies potential compliance risks, proposes mitigation strategies, and drives resolution of quality issues in collaboration with stakeholders.

7. Stakeholder Management & Influence
Builds strong relationships with internal and external partners, ensuring clear communication, trust, and long-term collaboration.

8. Innovation & Agility
Supports innovation by enabling compliant development of cutting-edge digital health solutions while adapting to evolving regulatory and business needs.

SCHEDULE 🕘:

• 08/09h -17/18h from Monday to Friday (flexible)

• 100% remote position

• Some business travel may be required

CONDITIONS 🌱:

• Salary package based on your profile. 

• Permanent Contract.

• Learning & Development.

Our goal is that you are well in every way!