Support the projects within Philips CTO (Research/Ventures) in assuring that products (and prototypes) are developed in accordance with applicable standards & regulations and QMS.
Quality Engineers support to build the Technical Files in case of (medical) Clinical Studies, they support the CTO Venture with product development, and Research projects that work closely with the business (e.g. WHSS) wrt Design Controls to speed up time to market, to increase quality and ensure safety.
The task of a Quality Engineer (QE) are:
1. Do Q Intake: determine the need for QE support based on the intended use and high level requirements which are input for the regulatory strategy document (by RA) (using the product release procedure)
2. Assist with defining the way of working and deliverables (in accordance with applicable standards & regulations and matching/tailoring the QMS) in the quality plan
3. In addition to the designated Risk Managers, provide risk management support in case the QE has required competences (e.g. assist with risk management plan and facilitate risk sessions)
4. Support the project with application of the defined way of working and creation of the compliant deliverables (maintain documentation structure)
5. Verify the way of working and deliverables for completeness, correctness and compliance. Track non-compliances to closure
6. Communicate with Q&R both within Research as well as in the business (where applicable) and escalate to the appropriate level in case non-compliances are not solved.
Must Have items:
- Experience with Q&R for product/software development in Research environment
- Experience with interpreting procedures in Quality Management system and applying in pragmatic way, tailored to Research projects.
- Team player, pragmatic, English speaking/reading/writing
- Knowledge of applicable ISO and IEC standards (e.g. ISO13485 (QMS), IEC62304 (Software for medical devices), ISO14791 (risk mgt))
- Experience with improvement projects, helicopter view
FT or 4/5 is also an option.