Senior Design Quality Assurance Engineer – Pharma

🔥 20 minutes ago

🌐 Portugal, Spain – Remote

🇵🇹 Portugal – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

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Ambit Iberia

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

💼 Consulting

🏥 Healthcare

Consulting • Healthcare

Ambit Iberia is a company specialized in providing digital solutions and regulatory and quality consulting services for the Life Sciences sector. The company offers a range of services including consulting in regulatory affairs, IT quality consulting, and the implementation of various ISO standards. With a strong focus on information technology, Ambit Iberia leverages its knowledge and experience to meet client needs in the rapidly evolving IT landscape.

📋 Description

• Provide strategic quality leadership for digital health products and GxP-relevant software platforms throughout the full product lifecycle • Ensure 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 and analytics, and other cross-functional stakeholders • Support teams on regulatory compliance requirements for medical devices, IVDs, and digital health solutions • Contribute as a Subject Matter Expert to design reviews, milestone reviews, audits, and regulatory inspections • Oversee documentation management, change control, product release, and complaint handling systems • Provide quality oversight for agile development activities • Support preparation and maintenance of validation and compliance documentation, including CSV activities • Identify quality risks and drive pragmatic, compliant solutions • Coach and support teams to strengthen quality culture, capability development, and knowledge sharing

🎯 Requirements

• 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 software engineering quality assurance • Experience with design controls and risk management • Experience with Computer System Validation (CSV) for GxP-relevant digital health platforms • Strong knowledge of FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366, and relevant cybersecurity requirements • Broad technical understanding of SDLC, systems engineering principles, cloud and SaaS platforms, system integrations, data analytics, and data flows • Practical experience in agile development environments such as Scrum, Kanban, or SAFe • Excellent communication, influencing, collaboration, judgment, negotiation, decision-making, conflict resolution, and relationship-building skills • Fluency in English • Ability to work Monday to Friday, 08/09h–17/18h, with flexibility

🏖️ Benefits

• Permanent Contract • Learning & Development • Flexible schedule • 100% remote work • Some business travel may be required

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