Quality Engineer II - Hardware

Organization
NanoString Technologies
Job Location
530 Fairview Ave N
Seattle, WA 98109
Salary
Competitive
Benefits

Benefits

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.
Job Description

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. 

Essential Duties:

  • 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. 

Requirements

Requirements:

  • BS in Life Science or Engineering discipline with a minimum of 3 years of experience in regulated industry including pharmaceutical and/or medical device, preferably with IVD (in vitro diagnostic device).

  • Strong knowledge and experience to ensure quality compliance in new product development and product lifecycle.

  • Working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971.

  • Proven ability to perform risk assessment and maintain risk management files.

  • Working knowledge in Quality system including CAPA, Change Control, and Nonconformance etc.

About Our Organization

NanoString Technologies is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications.

NanoString's products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under direction of Dr. Leroy Hood. The company was founded in 2003 with an exclusive license to develop and market the technology. In 2008, NanoString launched its first commercial instrument system and began international sales operations with its first multiplexed assays for gene expression analysis. In 2010, the company launched new applications for the system to support microRNA analysis and copy number variation detection, and in 2013 launched Prosigna®, its first in vitro diagnostic product for prognosis of early stage breast cancer.

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