Qualification & Validation Engineer
Core
Designing, coordinating, and executing validation processes for new products and technologies in the medical device industry.
Role type
Validation Engineer
Builds
Validated medical devices (injection needles) and related processes
Domain
Medical devices / Healthcare / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation process planning, validation strategy design, project management, quality management system knowledge, regulatory standards knowledge, MS Office proficiency
Preferred skills
Experience with revalidation processes, experience with newly installed technologies
Technologies
MS Office
Responsibilities
Prepare, coordinate, and execute validation processes; Design validation strategies; Plan and optimize validation and revalidation processes; Lead validation documentation; Support project teams in planning and executing new products and projects; Support implementation of new processes for newly installed technologies
Seniority
Mid-level, hands-on IC