Senior Design Quality Assurance Engineer | Pharma (100% Remote From Portugal Or Spain)

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.

At Ambit Iberia, we are committed to equal opportunities and workplace diversity. Applications from candidates with a certified disability of 33% or higher will be given due consideration, in accordance with applicable legislation.

Our goal is that you are well in every way!

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