Quality Assurance Engineer
The Quality Assurance Engineer is responsible for providing engineering process support in accordance with documented procedures and practices. The QA Engineer is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices.
- Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
- Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
- Bachelor’s Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
- Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
Designeers Midwest - 19 months ago