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.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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