Quality Engineer II - Medical Device - (Hillsboro, OR)

The Quality Engineer II serves as a resource to product development and manufacturing to improve product quality, reliability, and process capability and participate on teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. Under general supervision, responsible for quality planning & overall quality of new products being released to the market through participation in product development to ensure product and process conformance to global standards (including FDA and ISO 13485). Duties/Responsibilities Provide quality representation to design control, design verification and validation, design transfer, process validation, risk management, and specification development on assigned product development teams to assure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485. Participate on teams to ensure robust application of appropriate design and manufacturing controls. .