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Process Validation Expert
hace 2 semanas
About the Position
Viant Medical is seeking a highly skilled Process Validation Expert to join our team. As a process validation expert, you will be responsible for executing reviewing/approval of any documentation created/updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
Main Responsibilities
- Execute reviewing/approval of any documentation created/updated by the Manufacturing Engineering department (or other) required to sustain the manufacturing process or quality systems.
- Support in analysis, review, and implementation of new methodologies, processes, tools that contribute to the improvement on the manufacturing process, quality systems, or supplier improvements.
- Checks, provides support, and executes initiation/investigation for NCs, Complaints, Calibration, SCARs, and Environmental Monitoring.
- Provide follow-up to actions generated from corrective and preventive plans.
- Perform other duties, tasks, or projects at the direction of the immediate supervisor or other teammates.
Requirements
- Bachelor's degree in engineering or science (such as pharmacy, microbiology, physics, and chemistry).
- Bilingual English/Spanish - intermediate English level, reading and listening comprehension, writing, and oral expression.
- Basic knowledge of applicable regulations for the medical device industry (FDA, ISO, etc.).
- Basic knowledge in root cause analysis tools.
- Basic knowledge of process validation.
- Knowledge of Six Sigma Methodology and Lean Manufacturing is a plus.
- Knowledge of Minitab statistical software is a plus.
- At least 1-year work experience in a manufacturing environment.
- Project Management experience is a plus.
