we are looking for a Service & Delivery Quality Process Engineer.
In this role, you have the opportunity to
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
You are responsible for:
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
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
This position is open to all candidates.