The Engineer will lead implementation of single to multiple projects within the Quality Organization focused on automation and digitalization to drive growth, delivery, quality, and cost improvements.
The Engineer will coordinate, technical support with vendors, validations, managing resource requirements, timeline and change management tools for the local implementation.
Through the assignment, the Engineer will leverage internal and external data base and formulate business case and improvement strategies by enlisting and influencing cross-functional teams, delivering tangible business results through the application of FPX, Six Sigma and Lean methodologies and tools. At the same time will provide supervision to validation resources and programmers required in the process.
Requisitos:
A minimum of a Bachelor's Degree required (Engineering)
3-5 years of significant engineering and/or operational experience is required.
Medical device experience (21 CFR Part 820, ISO13485) highly preferred.
Write and execute validation protocols including but not limited IOPQ, CSV (Computer System Validation).
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