Our client is looking for a Project & Process Manager
Job description
We are looking for an experienced project manager who gets energy from further optimizing a process-driven organization in the exciting world of digital X-ray imaging.
Tasks as a project manager:
- Coordinate the activities of a cross-functional Project Core Team (marketing, applications, R&D, Validation, QARA, purchase, service, legal, supply chain,…) from the start till the launch of the product.
- Track project progress and budget, manage changes and mitigate project risks. Manage communication to all involved stakeholders.
- Work with third parties where you are involved in the nomination process, and act as technical single point of contact to define and monitor the statement of work.
Tasks as a process manager:
- Design, improve and document the Medical Solution Development processes based on analysis of the process requirements, regulatory needs, lessons learned and results from internal and external audits.
- Involve and align with experts to improve the process efficiency while maintaining a high product quality.
- Analyze process training needs and conduct process training.
- Support the whole R&D organization in its efficient use of the Solution Development processes into their daily work by acting as an independent reviewer and coach.
- Actively contribute to internal and external regulatory audits.
- Identify and solve process non-conformities and process CAPA’s.
Profile:
- Master’s degree or equivalent through experience.
- 3 to 5 years’ experience in an R&D, product development environment, preferably for medical devices (incl. software).
- A solid knowledge of Medical Quality regulations and standards is an asset, e.g. FDA design controls, ISO13485, ISO9001, European Medical Device Regulations…
- Strong organizer, problem solver and communicator, easily adapting to changes.
- A great coach with strong persuasive powers and skills to motivate people.
- Committed to delivering high standard medical software. In medical devices, quality is paramount.
- Fluent in English. Dutch is an asset.
