Design Quality Assurance Engineer – Pharma

🕒 vor 2 Tagen

🌐 Portugal, Spanien – Remote

🇵🇹 Portugal – Remote 🇪🇸 Spanien – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

👻 Geisterscore 10%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Warum dieser Wert:

• Seit 2 Tagen offen.
• Stellen bei diesem Unternehmen werden meist in 21 Tagen besetzt.
• Kein Gehalt angegeben.

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Ambit Iberia

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 2003

💼 Beratung

🏥 Gesundheitswesen

Consulting • Healthcare

Wir sind ein Unternehmen, das auf die Bereitstellung von Lösungen und Dienstleistungen im Bereich der Informationstechnologie (IT) spezialisiert ist.\n\nIm Rahmen von Engagement und Transparenz bieten wir durch die effiziente Integration unseres Wissens, unserer Erfahrung und fortlaufender technologischer Entwicklungen eine Reihe von Produkten, Dienstleistungen und Lösungen an, die darauf abzielen, Ihre Bedürfnisse in jedem Projekt oder Anforderung im dynamischen Bereich der Informationstechnologie effektiv und individuell zu erfüllen.

Beschreibung

• 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 appropriately 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 communicate compliance-related information and ensure project alignment • 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

🎯 Anforderungen

• 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 • Nice to have: experience working in international and multicultural environments, supporting internal and external regulatory audits or inspections, working with digital health or software-based medical products throughout their complete lifecycle, developing or improving quality capabilities/processes/tools, coaching colleagues or acting as a subject matter expert, stakeholder management and conflict resolution, document/data management systems, and cybersecurity risk management

🏖️ Vorteile

• Permanent Contract • Flexible Retribution Program (medical insurance, public transport ticket and childcare check) • Discounts on gym network (Wellhub) • Learning & Development • Flexible schedule • 100% remote position

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