Quality Engineer - Medical Device - (Hillsboro, OR)

Job overview! Within the AcuVentures department of Acumed, The Quality Engineer one (QE1) is responsible for providing Quality Assurance support to product development and manufacturing to increase product quality, reliability, and process capability. Participates on teams responsible for identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. Supports quality of new products being released to the market through participation in the product development process to ensure product and process conformance to global standards (including FDA and ISO 13485). Duties/Responsibilities Serves as a quality representative to design control, verification and validation, design transfer, process validation, risk management, and specification development on assigned product development teams ensuring compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.