- Collaborate with line supervisors, manufacturing engineers, and other team members to address quality opportunities in the assigned manufacturing line.
- Identify manufacturing process defects and contribute to the identification of root causes, corrective actions, and preventive measures.
- Perform line situation triage and initiate the exception management process as needed.
- Own basic exception and Corrective and Preventive Action (CAPA) activities with management oversight.
- Evaluate lot-to-lot yield and rework, ensuring adherence to quality standards.
- Review product specifications, quality plans, and documents, providing input to enhance product quality.
- Gain familiarity with process monitoring systems and contribute to process improvement efforts.
- Utilize quality tools and training materials to support problem-solving and continuous improvement initiatives.
- Conduct routine problem-solving investigations and implement minor changes through the change management system.
- Prepare protocols and reports to support engineering studies and validations.
- Bachelor's of Science or higher degree in Mechanical Engineering or Industrial Engineering or equivalent
- 0-1 years of industry experience in ISO-9001 environment, preferably medical device
- Basic technical knowledge of engineering concepts, practices, and procedures.
- Ability to work in a quality system environment.
- Strong analytical and problem-solving skills.
- Effective communication and collaboration abilities.
- Ability to work under general supervision and make decisions within a limited scope.
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