Supporting the QMS deployment, integration and standardization programs in CTO Ventures organization of Philips.
Key areas of responsibilities for this role include:
- Supporting the maintenance, enforcement, and management of a compliant and effective CTO Ventures QMS
- Managing gap assessments towards ISO 9001, ISO 13485, 21 CFR 820 and EU MDR
- Supporting the transition to the "end state" of the CTO Ventures according to the Philips Excellence Process Framework
- Data collection and analyses related to performance measuring and related affairs
- Supporting the training and training administration as per the QMS and contributes to training curriculum setup according to the Philips Business System.
- Supporting the Change Control process by driving assigned Change Requests to closure (CCB)
- Supporting the corrective and preventative action process deployment (CRB)
- Supporting the execution of the management review process
You are a part of
The CTO organization Q&R team. The Q&R team maintains, deploys and supports the research projects and ventures within the chief technology office. You will be working with various stakeholders from procurement, privacy, security, product development and regulatory affairs functions. You will be reporting to the Sr. Q&R Manager ? CTO Ventures.
To succeed in this role, you should have the following skills and experience
A person who is excited by the unique professional challenges that our Quality Transformation presents, with strong technical competencies, and demonstrates resilience challenging, often demanding situations. Specific skill requirements for this role:
- Bachelor´s degree is required
- Minimum 2 years of experience working within a worldwide Medical Device or Pharma company is required.
- Minimum 2 years of experience in QMS is required.
- Understanding of ISO 9001, ISO 13485, 21 CFR 820 and EU MDR/IVDR is preferred.
- Project management experience, supporting (complex) projects where not directly responsible for all required deliverables
- Good communication skills across all levels and cultures of the organization
- Able to analytically assess impact to the CTO Ventures QMS and the local organization of End-to-end programs.
- Able to proactively and independently resolve issues in creative ways
- A hands-on mentality
- Highly proficient in spoken and written English