We are looking for a "Software Quality Manager" who will offer service to a multinational pharmaceutical company.
➥Key objectives of the role:
Participate in the establishment and maintenance of a Quality Management System according to ISO13485 for Digital Solutions developed and/or maintained by the Company.
Responsible to provide input, define procedures or lead improvement initiatives to the technical elements of the QMS as the subject matter expert in software development.
Responsible for ensuring instructional quality documents (QAPs, SOPs, WIs, templates, checklists) are created and maintained as part of the QMS.
Creation, review and/or approval of documentation that are part of the ecosystem or infrastructure that support or interface with the software medical device.
Perform quality and technical reviews of documents/deliverables to ensure compliance with relevant standards or procedures in place for the products developed and maintained by the Digital organization.
Set up and conduct software hazard analysis and product risk analysis according to ISO14971. Creation, review and/or approval of product risk files for the products developed by the Digital organization.
Review potential product risks as well as propose and document risk minimization in conjunction with the Digital Solution Owner, Medical Affairs, Usability Validation Scientist and Cybersecurity expert as the main stakeholders.
Quality-related support of the interfaces to development and test activities with focus on product quality. Establishes and monitors requirements and control indicators for product quality as a decision basis including identification and evaluation of anomalies and deviations over the product lifecycle.
Actively participates at planning and review-meetings as well as daily status meetings if needed. Analyses requirements and user stories for testability. Ensures that design specifications are verifiably and appropriate to fulfil the set quality goals and regulatory requirements. Review and evaluation of product changes affecting product design.
Professional experience (+5 years) in the area of development, testing, and/or quality assurance of software preferably within a regulated environment.
Experience in software development using an agile methodology (e.g. Scrum, Kanban).
Experience in end-to-end “Product Quality by Design”, covering requirements engineering, system integration, test, verification and validation strategies, and advanced quality planning.
Experience in software development and preferably software verification within a regulated environment, in particular IEC 62304 (e.g. software architecture, code review, software testing, cybersecurity, and additional knowledge of the IEC 82304 is of advantage).
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Acerca de Ambit BST
¡Hola! Somos Ambit BST (Building Solutions Together), una empresa joven y dinámica con sede principal en Barcelona. Nuestra razón de ser consiste en generar un valor diferencial en la prestación de servicios y soluciones tecnológicas para las empresas, focalizándonos especialmente en el sector farmacéutico y de la Salud.
¿Qué nos hace especiales? Lo llevamos en el nombre: “construyendo soluciones juntos”. Nuestras herramientas para construir se basan en poner siempre a las personas en primer plano, ser adaptables y perseguir la mejora continua. En Ambit BST sabemos que tú eres la pieza clave para que podamos seguir construyendo juntos, así que ¡queremos encontrarte!”