What are the responsibilities and job description for the Design Quality Engineer position at Katalyst Healthcares and Life Sciences?
Roles & Responsibilities :
- 2-5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes.
- Participate in the governance, and execution of the Quality Management sub-system element of Design Change.
- Required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities.
- Will lead specific quality improvement projects as required to support QT and other business initiatives including but not limited to audits (internal / external), supplier quality, CAPA, and training.
- Participate as a core team member on various design changes.
- Provide assistance to the engineering partners in the development of design verification and validation testing requirements including protocol development, test methods, acceptance criteria, and statistical plans / techniques.
- Support the development, monitoring, and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC.
- Support internal and external audit needs while serving as the subject matter expert for Design Quality Assurance.