What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Work closely with operations and the business functions to ensure quality performance of products and processes.
- Initiation and ownership of NC and CAPA, builds proficiency in problem-solving and root-causing activities.
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Review of change management activities.
- Maintain KPIs for monitoring of process and supplier quality, perform analysis and interpret trends, and take action as necessary.
- Support execution and analysis of QATs.
- Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
- Develop an understanding of risk management practices and concepts and become proficient in process risk.
- Develop an understanding of optimization of inspection methods and sampling. Support First Article Inspections.
Requirements :
