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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Design Quality Assurance Engineer | Pharma (100% remote from Portugal or Spain) - **Company:** Ambit Iberia - **Location:** Sant Cugat del Vallès, Spain (Remote available) - **Contract:** Permanent contract - **Skills:** Agile Methodology, Computing Platforms, Systems Engineering, Software as a Service, Cloud Computing, EHealth, Integrated Development Environments, Scrum Methodology, Software Engineering, Data Streaming, System Testing, Systems Integration, Data Analytics, GXP - **Published:** November 13, 2026 - **Apply:** https://www.jobleads.com/es/job/senior-design-quality-assurance-engineer-pharma-100-remote-from-portugal-or-spain--sant-cugat-del-valles--e5d75215d5ff77421c2b11660d9e3ce19 ## About the Role + 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: o Software engineering quality assurance o Design controls and risk management o Computer System Validation (CSV) for GxP-relevant digital health platforms + Strong knowledge of applicable regulations and standards, including: o FDA QSR o ISO 13485 o ISO 14971 o IEC 62304, IEC 82304, IEC 62366 o Relevant cybersecurity requirements + Broad technical understanding of: o Software Development Life Cycle (SDLC) o Systems engineering principles o Cloud and SaaS platforms o 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. ## Description 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: o Software engineering quality assurance o Design controls and risk management o Computer System Validation (CSV) for GxP-relevant digital health platforms + Strong knowledge of applicable regulations and standards, including: o FDA QSR o ISO 13485 o ISO 14971 o IEC 62304, IEC 82304, IEC 62366 o Relevant cybersecurity requirements + Broad technical understanding of: o Software Development Life Cycle (SDLC) o Systems engineering principles o Cloud and SaaS platforms o 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!