Design Quality Assurance Engineer – Pharma

🔥 14 hours ago

🌐 Portugal, Spain – Remote

🇵🇹 Portugal – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Represent Design Quality Assurance within project teams, ensuring sustainable compliance across assigned projects and work areas • Provide proactive Design Control quality support throughout product development and product care activities • Participate in the generation, review, and approval of Design Control documentation and deliverables • Support the planning and execution of Design Control deliverables, project milestones, and design reviews • Identify, prioritize, and address Design Quality issues that may impact regulatory status • Support implementation of Design Controls, development methodologies, and quality processes • Drive and support Risk Management processes throughout the medical device product lifecycle • Provide quality guidance and educate business and project teams on quality topics, compliance requirements, and best practices • Support internal and external audits and inspections as a subject matter expert • Collaborate with Quality and Regulatory teams to ensure compliance alignment across projects • Build and maintain relationships with cross-functional stakeholders • Contribute to continuous improvement and innovative solutions to quality and compliance challenges • Support and act as a proxy for other Product Quality team members when required • Coach colleagues in quality and compliance expertise • Maintain document management processes and control quality-related documentation

🎯 Requirements

• Bachelor's or advanced degree in Science, Software Engineering, or a related field • 5+ years of experience in Quality Assurance within the Digital Health industry or a related field • Proven experience in Software Quality Engineering or Quality Assurance within regulated industries such as Medical Devices, In-Vitro Diagnostics, Pharma, or Digital Health • Strong knowledge of Design Controls and quality processes applied to software and medical device development • Technical understanding of software, systems development, and software development tools • Experience implementing and improving Design Controls, development methodologies, and related quality tools and processes • Proven experience implementing and maintaining Risk Management processes throughout the medical device product lifecycle • Experience with software development methodologies such as SAFe, Scrum, Kanban, or similar Agile frameworks • Knowledge of digital health standards and regulations, including FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366 • Knowledge of cybersecurity standards applicable to medical devices and digital health products • Experience with quality systems and tools supporting document management, data and change control, product release, and complaint handling • Strong communication, negotiation, and influencing skills • Ability to navigate complex situations, manage shifting priorities, and work effectively across multidisciplinary teams • Fluent English, with the ability to communicate clearly and precisely in complex and international environments • Experience working in international and multicultural environments • Experience supporting internal and external regulatory audits or inspections • Experience working with digital health or software-based medical products throughout their complete lifecycle • Experience developing or improving quality capabilities, processes, and supporting tools • Experience coaching colleagues or acting as a subject matter expert within Quality Assurance • Strong stakeholder management and conflict resolution skills • Proactive mindset with strong ownership, resilience, and accountability • Ability to adapt effectively to changing priorities and complex project environments • Experience with document and data management systems supporting regulated product development • Familiarity with cybersecurity risk management within software-based medical devices

🏖️ Benefits

• Flexible Retribution Program (medical insurance, public transport ticket and childcare check) • Discounts on gym network (Wellhub) • Learning & Development • Flexible schedule • Permanent contract