Project & Process Manager

For a leading international player within an innovative and highly regulated environment, we are looking for an experienced Project & Process Manager.

You will join an organization active in digital imaging and medical technology, where quality and innovation are key.

Job description

We are looking for an experienced project manager who gets energy from further optimizing a process-driven organization in a high-tech environment.

Tasks as a project manager

• Coordinate the activities of a cross-functional Project Core Team (marketing, applications, R&D, validation, QARA, purchasing, service, legal, supply chain, ) from start to product launch.
• Track project progress and budget, manage changes and mitigate project risks. Manage communication with all stakeholders.
• Work with third parties, being involved in the nomination process and acting as the technical single point of contact to define and monitor the statement of work.

Tasks as a process manager

• Design, improve and document solution development processes based on process requirements, regulatory needs, lessons learned and audit results.
• Align with internal experts to improve process efficiency while maintaining high product quality.
• Analyze process training needs and deliver training where required.
• Support the R&D organization in using development processes by acting as an independent reviewer and coach.
• Contribute to internal and external audits.
• Identify and resolve process non-conformities and CAPAs.

Profile

• Master's degree or equivalent through experience.
• 3 to 5 years of experience in an R&D or product development environment.
• Experience in a regulated environment is a strong plus (e.g. medical devices, pharma, high-tech).
• Knowledge of quality standards and regulations is an asset (e.g. ISO13485, ISO9001, FDA guidelines, MDR).
• Strong organizational, problem-solving and communication skills.
• Able to adapt easily in a dynamic environment.
• Strong coaching and stakeholder management skills.
• High focus on quality and structured way of working.
• Fluent in English. Dutch is a plus.