Senior Process Analyst (Quality)

Description

Job Summary: Lead the structuring and optimization of organizational processes, ensuring ISO certifications for medical devices and healthtech solutions while promoting continuous improvement and a quality culture. Key Highlights: 1. Lead the structuring and optimization of organizational processes 2. Focus on ISO certifications (ISO 13485, ISO 9001, ISO 14001, ISO 45001) 3. Continuous improvement in R&D using agile methodologies and quality tools * Lead the structuring, standardization, and optimization of organizational processes, ensuring attainment and maintenance of relevant ISO certifications (with emphasis on **ISO 13485** for medical devices**, ISO 9001, ISO 14001, and ISO 45001**), guaranteeing compliance, traceability, and technical excellence in hardware development and healthtech solution projects. * Strategically drive continuous improvement across Research and Development (R&D), engineering, prototyping, testing, and validation workflows by applying agile methodologies and quality tools to accelerate innovation, reduce risks, and increase operational efficiency. * Serve as the liaison between technical teams, support departments, and senior management, fostering a quality culture, process governance, standardization, and results orientation. * Map, analyze, review, and document R&D, hardware development, and embedded software development processes using structured methodologies (e.g., BPMN). * Structure and implement all documentation required for ISO certifications and audits, ensuring adherence to standards, organization of evidence, and readiness of involved departments. * Develop, monitor, and analyze performance indicators (KPIs), enabling data-driven management for tracking efficiency, quality, and compliance. * Propose and implement process improvements by identifying bottlenecks, reducing waste, and increasing productivity using tools such as PDCA, Lean, Six Sigma, among others. * Support risk management, regulatory compliance, and applicable requirements for medical device and healthtech solution development. * Conduct internal training sessions, workshops, and capacity-building activities on quality management, processes, certifications, and agile methodologies.