Service & Delivery Quality Process Engineer

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:

• Facilitating, participating, and communicating QMS service activities and projects between different departments, sites, and businesses
• Initiating, stimulating, and supporting the implementation of process improvements
• Facilitating, managing, and supporting internal and external audits in all business processes
• Supporting and advising the organization in corrective and preventive actions (CAPA)
• Participating in the maintenance and improvement of the Quality Management System
• Supporting and participating in the implementation of Quality transformation projects
• Facilitating and participating in applying risk management tools, assessments, processes, and principles
• Translating regulations and standards and bringing 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
• Interacting with local and global functions across multiple the businesses

You are a part of:

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.

To succeed in this role, you should have the following skills and experience:

• 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., ISO
  13485 / 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.

Indicate if this role is an office/field/onsite 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.