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

SKILLS :

Education & Experience

- Bachelor’s or advanced degree in Science, Software Engineering, or a related discipline.

- 5+ years of experience in Quality Assurance and Computerized System Validation (CSV) within regulated environments such as digital health, medical devices, IVD, or pharmaceuticals.

Technical & Regulatory Expertise

- Proven experience in quality and regulatory roles related to:

- Software engineering quality assurance

- Design controls and risk management

- Computer System Validation (CSV) for GxP-relevant digital health platforms

- Strong knowledge of applicable regulations and standards, including:

- FDA QSR

- ISO 13485

- ISO 14971

- IEC 62304, IEC 82304, IEC 62366

- Relevant cybersecurity requirements

- Broad technical understanding of:

- Software Development Life Cycle (SDLC)

- Systems engineering principles

- Cloud and SaaS platforms

- System integrations, data analytics, and data flows

- Practical experience working in agile development environments (e.g., Scrum, Kanban, SAFe).

Soft Skills & Competencies

- Excellent communication skills, with the ability to clearly explain complex quality and regulatory topics.

- Strong influencing and collaboration skills within matrix and cross-functional organizations.

- Proactive, solution-oriented mindset with solid business acumen.

- Ability to navigate ambiguity and complexity while maintaining a strong compliance focus.

- Coaching mindset, fostering capability development and continuous improvement.

- High level of resilience, accountability, and flexibility in fast-changing environments.

- Sound judgment, negotiation, and decision-making capabilities.





- Ability to address conflicts constructively and build trust-based relationships.

- Fluency in English, with the ability to communicate confidently and influence in complex, technical discussions.

TASKS & RESPONSIBILITIES :

- Provide strategic quality leadership for digital health products and GxP-relevant software platforms throughout the full product lifecycle.

- Ensure effective implementation and maintenance of design controls, risk management, and quality processes in software development environments.

- Act as the primary quality interface between software development, digital infrastructure, data & analytics, and other cross-functional stakeholders.

- Support and guide teams on regulatory compliance requirements for medical devices, IVDs, and digital health solutions.

- Contribute as a Subject Matter Expert (SME) to design reviews, milestone reviews, audits, and regulatory inspections.

- Oversee and support key quality processes, including documentation management, change control, product release, and complaint handling systems.

- Provide quality oversight for agile development activities, ensuring compliance without compromising delivery speed or innovation.

- Support the preparation and maintenance of validation and compliance documentation, including CSV activities.

- Proactively identify quality risks and drive pragmatic, compliant solutions in complex and ambiguous scenarios.

- Coach and support teams to strengthen quality culture, capability development, and knowledge sharing

SCHEDULE :

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

- 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

📌 Senior Design Quality Assurance Engineer | Pharma (España)
🏢 Ambit Iberia
📍 España