Quality Engineer 2 - Katalyst Healthcares & Life Sciences
Walpole, MA 02032
About the Job
Responsibilities:
- 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.
- 2-5 years of experience in 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.
Source : Katalyst Healthcares & Life Sciences