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Job title:

Supporting the maintenance, enforcement, and management of a compliant and effective QMS.

Your role:

• Maintain and enforce a compliant and effective QMS for Q&R processes and Product Quality, ensuring adherence to regulatory requirements for both medical and non-medical devices

• Collaborate with Quality Managers from other areas of the organization to complete and maintain the QMS, with a strong emphasis on Product Development, Launch & Maintenance of innovative products

• Establishing transition plans, executing impact assessments for the QMS, setting actionable goals, and ensuring the effective application of Q&R requirements across all processes managed through change control

• Manage and harmonize internal processes to facilitate effective bi-directional communication between QMS and Philips Intellectual Property & Standards and Philips Research, ensuring compliance with new or changing Regulations

• Coordinate and align internal and external audits to maintain QMS compliance and certification to external standards, own and lead CAPA

• Establish proper document control procedures and assign training profiles, ensuring effective training administration

• Maintain a network within the company focused on Q&R topics, in line with business needs and key stakeholders

• Actively participate in discussions, mentor and develop colleagues, and contribute to various initiatives by presenting specific topics related to Q&R

• Supporting the training and training administration as per the QMS and contributes to training curriculum setup according to the Philips Business System

• Supporting the execution of the management review process

You're the right fit if:

• Bs or MSc degree in Science

• At least 5-6 Years of experience in highly regulated industries, preferable medical devices

• Experience as Quality Manager, managing a variety of processes such as Regulatory submission (FDA, EU-MDD/MDR, CFDA), post-market surveillance, set up and maintain QMS

• The ability to integrate compliance and ethics with operational excellence in an innovative environment

• Good understanding of and experience with Software dominant and Artificial Intelligence enabled solutions would be highly preferred

• Strong stakeholder management and relational skills to help you collaborate in a multi-stakeholder landscape

• Team worker, able to bring teams to a higher level

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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