Key skills
PMPRCommunicationProblem SolvingPresentation Skills
About this role
Role Overview
- Work and report directly to the Head of Quality Radiology Informatics
- Collaborate with the extended PSQ and Markets Q&R teams
- Execute tactical activities with cross functional Quality activities and projects to support customer needs
- 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
- Translate regulations and standards and bring them to consolidation in the organization
- Participate in and verification of changes to QMS impacting service
- Responsible for performing timely, SW Quality Engineering tasks
- Assess software design and review tests and other performance data
- Interact with local and global functions across multiple businesses
Requirements
- 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
Tech Stack
- PMP
Benefits
- Onsite roles require full-time presence in the company’s facilities
- Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations