Senior Quality Project Engineer

The Senior Quality Project Engineer is responsible for providing quality leadership for business-initiated projects, including New Product Development (NPD), product sustainment, customization, innovation initiatives, and Transfer of Work (ToW) activities. As a core member of cross-functional project teams, the Senior Quality Project Engineer represents the Quality function and ensures that quality, regulatory, and compliance requirements are effectively integrated throughout the entire product and process lifecycle.

This position reports to the Director QA – Single Use Technologies, Projects and Continuous improvement and is part of the Upstream and Fluid Management QA & RA organization located in Hoegaarden, Belgium and will be an on-site role.

What you will do:

• Provide quality oversight and guidance throughout design transfer, process development, verification, validation, and commercialization activities.
• Support successful transfer of products and processes from development to routine manufacturing, establishing robust quality controls and monitoring strategies to ensure consistent product quality and process performance.
• Partner with Product Management, RD&E, Manufacturing Engineering, Regulatory Affairs, Supply Chain, Supplier Quality, Global Sterility Assurance and Operations to support robust product and process development while ensuring successful project execution
• Author, review, approve, and maintain validation protocols, reports, and other quality-related project documentation in compliance with applicable procedures and standards.
• Leverage complaint investigations, CAPAs, non-conformances, audit observations, and other quality data sources to drive continuous improvement and strengthen quality-by-design principles within product development activities

Who you are:

• Master or bachelor’s degree in applicable field or equivalent by experience in Quality in a similar (GMP)/ISO regulated BU/Industry.
• 5 + years of relevant quality experience of which at least 3 years of applicable industry experience.
• Can work independently as a quality lead within a cross-functional team to support successful implementation of new projects and products.
• Validation/qualification experience and project management are a must.
• Strong working knowledge of quality assurance principles and practices, industry and international regulations and standards (ISO9001 and/or ISO134585).

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel 5-15% (domestic and international).

It would be a plus if you also possess previous experience in:

• Knowledge of ISO11137, ISO14644 and ISO14698 is a plus.
• Statistical improvement tools and lean manufacturing techniques.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.