Service & Delivery Quality Process Engineer

• Work and report directly to the Head of Quality Radiology Informatics. Also working directly with the extended PSQ and Markets Q&R teams.
• Execute tactical activities with cross functional Quality activities and projects to support customer needs, RI strategy implementation and EI business success.
• Support the implementation of Quality transformation projects

• Facilitate, participate, and communicate QMS service activities and projects between different departments, sites, and businesses
• Initiate, stimulate, and support the implementation of process improvements
• Facilitate, manage, and support internal and external audits in all business processes
• Support and advise the organization in corrective and preventive actions (CAPA)
• Participate in the maintenance and improvement of the Quality Management System
• Supports and participates in the implementation of Quality transformation projects
• Facilitate and participate in applying risk management tools, assessments, processes, and principles
• Translate regulations and standards and bring them to consolidation in the organization and the Quality Management System
• Participation in and verification off changes to QMS impacting service
• Responsible for performing timely, SW Quality Engineering tasks: assessing software design and reviewing tests and other performance data, analyses market feedback, completing or assisting with in the root cause analysis and SW Quality problem solving
• Interact with local and global functions across multiple the businesses

You are part of a dynamic team that develops software as a medical device, this role is an integral part of the Quality organization under the Radiology Informatics Business Unit.

• Bachelor's degree – preferred software / technical / engineering background
• 5+ years of experience in Q&R roles within medical device industry, including software as a medical device
• Familiarity with relevant standards and regulations, e.g., ISO13485 / MDSAP / MDD & EU-MDR / CFR
• Experience in leading multi-location activities and projects under a regulatory scope
• Effective interpersonal and communication skills. Strong oral and presentation skills in English
• Familiar with Problem Solving techniques and Root-Cause analysis
• Experienced with Excel, PowerPoint, Word - capable to acquire further IT tools ability
• Self-starter, motivated, and energetic
• PMP Certification – preferred
• Data analysis knowledge and experience– preferred
• Experience with service and delivery of software – highly preferred