subsystem architects and external partners, while managing technical debt and prioritizing customer-centric non-functional requirements. Ensure software compliance with medical regulatory standards like FDA, MDR, IEC 62304 and ISO 13485.Maintain comprehensive documentation to support regulatory submissions, audits, and compliance reviews. Collaborate with global R&D teams and stakeholders in marketing, PMO, quality, regulatory, and service functions.Serve as a … teams in multiple product launches. Your skills include a strong background in clinical applications, systems integration, interoperability, and knowledge of medical device regulations like IEC 62304, FDA, MDR, and ISO 13485.You are familiar to work in agile development methodologies like SAFe, apply AI/ML technologies, and are able to solve problems using modern C++ code. You have a More ❯
Description Job Posting Description In this role, you have the opportunity to Be involved in the development of Philips CDS software, within the Tools team. In compliance with the ISO standards applied to the medical sector (ISO13485), you will participate in the creation of tools used by our development teams. You will propose a technical design … inclusion here . Rattaché au responsable du développement, vous intervenez sur le développement des logiciels de Capsule Technologie au sein de l'équipe Tools. Dans le respect des normes ISO appliquées au médical (ISO13485), vous participerez à la réalisation des outils utilisés par nos équipes de développement. Vous proposez un design technique, vous écrivez le code More ❯
to continual process improvement across the business. Responsibilities as a Quality Systems Engineer in Andover. Develop and maintain the Business Management System and supporting software platform. Ensure compliance with ISO 9001, AS 9100, ISO13485, and related standards. Conduct investigations using 8D, Ishikawa, and 5WHY methodologies. Lead or support internal audits and prepare for certification, regulatory, and … system performance. Requirements as a Quality Systems Engineer in Andover. 3+ years of experience in quality management within manufacturing or product development. Strong working knowledge of ISO9001, AS 9100, ISO13485, and ISO14001. Degree in Electrical or Mechanical Engineering (or equivalent experience). If you are interested in this Quality Systems Engineer job in Andover. then APPLY NOW. More ❯
