Quality Engineer 2
Quality Engineer 2
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- The Design Quality Engineer will participate in the governance and execution of the Quality Management subsystem element of Design Chnage.
- 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.
- 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
- 25 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.
Employment Type
Full Time
