AdresHold a pivotal position to disrupt Medtech and make a real difference for patients.
The FORS group is a dedicated corporate venturing organization tasked to create new solutions for IGT, focusing on procedure innovation and new business model development in the cardio-vascular domain.
FORS is a unique technology that enables real-time 3D visualization of the full shape of devices inside the body without the need for fluoroscopy thus allowing us to break through the current limitations of image guided therapy by reducing the dependency on fluoroscopy while vastly improving the visualization of intra-body devices.
More about FORS: www.Philips.com/FORS-technology
In this customer-centric, fast-learning and agile venture environment we value drive, creativity and solution oriented end-to-end business thinking, and we are looking to hire a QMS Manager that will actively engage with the key people of the FORS team.
Here you will establish and operationally execute quality strategies, based on a deep understanding of the quality management system processes as well as normative and regulatory requirements.
Your role:
Ensures compliant and effective QMS’s are maintained in scope.
Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure.
Accountable to manage and harmonize all QMS management processes
Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.
Ensures Q&R requirements are effective in all processes in scope
Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
Managing CAPAs and supporting the CAPA process
You're the right fit if:
Experience in medical QMS (e.g. ISO 13485)
Knowledge in regulatory affairs (e.g. EU MDR)
Rich experience in the field of document reviews, CAPA and improvement projects
Project management skills
Hands-on mentality
Team Player
Preferable experience in working in venture / start-up setups incl. basic business understanding
Innovative mindset & entrepreneurial spirit, hands-on approach
Excellent analytical and conceptual skills and structured way of working
Passionate personality with outstanding communication and interpersonal skills
About Philips
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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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