Job Description
As Service & Delivery Quality Process Engineer you will be 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.
You will have the opportunity to 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.
Your Role:
- 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’re the right fit if you have:
- Bachelors degree – preferred software / technical / engineering background
- 8-10 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
- How we work together
- We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
- 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.
This role is an office role.
