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

Company: Ambit Iberia

Job 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:
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 🕘:

Our goal is that you are well in every way!