Your Responsibilities Represent QA in global cross-functional device development project teams, quality board meetings, and development gate reviews Provide quality oversight and scientific guidance across assigned medical device development projects, ensuring alignment with regulatory and internal requirements Develop and contribute to project strategies, including risk assessments and contingency planning, to secure timely delivery of quality milestones Act as QA approver for technical documentation, deviation records, and OOX entries (e.g. Trackwise system) Support and coordinate Notified Body inspections, including preparation and hosting activities Contribute to the authoring and maintenance of QMS documentation (SOPs, Work Packages, Forms, Attachments) Conduct and support impact assessments for design changes, manufacturing modifications, and evolving regulatory standards Manage project trackers and prepare relevant materials for governance and management forums Provide input to QA agreements and contracts with third-party partners and approve project-specific amendments