Senior Design Quality Assurance Engineer | Pharma (100% remote from Portugal or Spain)
Ambit Iberia
Remoto
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.
- 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).
- 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.
- 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
- 08/09h -17/18h from Monday to Friday (flexible)
- 100% remote position
- Some business travel may be required
- Salary package based on your profile.
- Permanent Contract.
- Learning & Development.