The Quality Engineer - Hardware shall provide technical quantitative, and coordination support to assure products and processes are designed, deployed, and operated according to requirements. Work scope of this position includes: quality engineering, support for design controls, risk management processes, tech transfer to operations and quality oversight over the manufacturing processes.
Ensure consistent implementation, improvement and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QRS), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD).
Individual is a team player participating on design transfer project teams to provide leadership in design control and risk management practices include working among different business units within the company. In addition, individual can also work independently as needed and is capable work well on fast-paced environment.
Participate in new product development (NPD) projects to provide quality oversight for design control as well as risk management activities.
Lead and facilitate Risk Management activities during product development as well as product lifecycle, and maintain Risk Management file.
Provide Quality support for day to day activities.
Create and/or review technical documents, such as plans, reports, and procedures, etc.
Can lead quality related problem solving and root cause analysis.