Ambit Iberia

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 (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!