We are looking for aSenior Design Quality Assurance Expertfor one of our clients in the Digital Health / Life Sciences Sector.SKILLSBachelor's or Master's degree in Science, Software Engineering, Biomedical Engineering, or a related discipline.Experience:+5 years of professional experience in Quality Assurance within regulated environments (Medical Devices, IVD, Pharma, Digital Health).
Strong expertise in software quality engineering and design controls across the full product lifecycle.Proven experience applying risk management methodologies (ISO *****) and design control processes.Solid knowledge of global regulatory standards and frameworks, including:FDA QSRISO *****ISO *****IEC *****, IEC *****, IEC *****Relevant cybersecurity standardsExperience supporting documentation management systems, change control, product release processes, and complaint handling.Hands-on experience participating in audits, inspections, design reviews, and milestone reviews as a subject-matter expert.Practical experience working in agile development environments (Scrum, Kanban).
Strong technical understanding of software development lifecycles, systems engineering, and associated toolchains.Fluency in English, with ability to communicate precisely and confidently in complex technical and regulatory discussions.TASKS & RESPONSIBILITIESDesign Quality Leadership Provides strategic quality leadership within cross-functional teams, ensuring digital health products comply with global regulatory requirements throughout the development lifecycle.Regulatory Compliance & Standards Application Applies design controls, risk management, and quality standards (FDA QSR, ISO, IEC) to ensure compliant, high-quality software and system solutions.Cross-Functional Collaboration Acts as a key bridge between software development, product management, regulatory, and quality teams, fostering alignment and efficient delivery.Documentation & Quality System Support Supports document management, change control, product release activities, and complaint handling processes in accordance with quality management system requirements.Audit & Inspection Support Serves as a subject-matter expert during audits, inspections, design reviews, and milestone reviews, ensuring readiness and regulatory alignment.Risk Management & Problem Solving Identifies potential compliance risks, proposes mitigation strategies, and drives resolution of quality issues in collaboration with stakeholders.Stakeholder Management & Influence Builds strong relationships with internal and external partners, ensuring clear communication, trust, and long-term collaboration.Innovation & AgilitynSupports innovation by enabling compliant development of cutting-edge digital health solutions while adapting to evolving regulatory and business needs.SCHEDULE*****h – *****h from Monday to Friday (flexible)100% remote positionSome business travel may be requiredCONDITIONSSalary package based on your profile.Permanent Contract.Learning & Development.Our goal is that you are well in every way!
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