Quality Engineer 2 - Katalyst Healthcares & Life Sciences

• 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.

Requirements:

• 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.

• The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Design Change.

• Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities.

• Additionally, this role 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.