Senior Design Quality Assurance Engineer | Pharma (100% remote from Portugal or Spain)

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

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CONDITIONS 🌱:

* Salary package based on your profile.

* Permanent Contract.

* Learning & Development.

Our goal is that you are well in every way!