Job Information
Nanostring Quality Control Inspector II in Mill Creek, Washington
Our Mission is to Map the Universe of Biology. Improving the human condition is what fuels our passion for finding new ways of enabling scientific exploration. As a company, we strive to create end-to-end solutions that are simpler, easier, faster and more relevant to today's life science challenges. As the pioneer in the field ofspatial biology,NanoStringenables scientists across the globe to envision molecular interactions in three dimensions with three different systems, the, the(DSP) and the(SMI) platform. As a result, scientists can see themultiomicexpression of genes and proteins in the natural context of tissue structure. Since our founding in 2003, we have earned a reputation as a respected, trusted pioneer of innovative technologies that support our customers in their relentless pursuit of answers. Our products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under the direction of Dr. Leroy Hood. With our technologies, our customers continue to extend our understanding of biology to answer previously unsolvable questions with consistent, reliable results. However,NanoStringis much more than innovative products. The secret sauce to the company's success is our people, who are committed to excellence and dedicated to catalyzing the next biological revolution. Collectively, we live our corporate values of ambition, grit, ingenuity, authenticity, and customers every day...and never stop asking "What if?" The Quality Control Inspector II (QCI) is responsible for initial Quality Control inspections of all NanoString incoming raw materials, components and sub-assemblies received at our facilities per inspection plan. QCI is also responsible for all finished instrumentation testing of all final assembled instruments per inspection plan. The scope of this position is includes performing all necessary quality control checks, including FAIRs (First Article Inspection Reports), using appropriate testing procedures and test instrumentation supported with appropriate documentation for all Nanostring products to manage quality risk and provide oversight over manufacturing processes. This position reports into the compliance and certifications manager which is part of Quality organization. The individual ensures consistent implementation, improvement, and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD) and In-Vitro Diagnostic Regulation (IVDR). Requirements: Technical diploma or equivalent BS in technical discipline with hands-on experience in a regulated industry. At least 3 years of experience as a QC inspector in a regulated environment i.e., medical device/ biotechnology/ aerospace industry. Analytical and creative problem-solving skills that include experience in leading and or participating on process improvement/lean projects. Excellent written and oral communication skills. Ability to work independently and collaboratively in cross-functional teams. Ability to multi-task with demonstrated problem solving skills in a fast-paced complex environment. Proficient in use of MS Office. Essential Responsibilities: Perform incoming and final quality control inspections to support Manufacturing and Operations quality for all NanoString instruments following latest Incoming Specifications Update incoming inspection specifications and procedures as required, in collaboration with other affected departments. Record non conformances and support in conducting root cause investigations. Manage nonconforming (or potentially nonconforming) material through disposition. Perform lot validation testing while monitoring and adjusting testing frequencies. Support r