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Nanostring Quality Assurance Associate in Mill Creek, Washington

Our Mission is to Map the Universe of Biology. As the pioneer in the field of, NanoString enables 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 the multiomic expression of genes and proteins in the natural context of tissue structure. 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. Summary: The Quality Assurance Associate II is responsible for supporting the NanoString Quality Management System (QMS) process. Primarily responsibilities will include creating and modifying standard operating procedures, Quality Assurance (QA) product release, administration of change management and document control processes, and auditing. 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). Requirements: Minimum Education: Bachelor's degree in a related field strongly preferred. Minimum Experience : 3-5 years quality-related experience in the pharmaceutical or device industry. Specialized Knowledge: Strong understanding of applicable regulations and standards (21 CFR 803, 806, 820, and ISO 13485). Problem Solving and training skills. Practical experience/training in quality systems management, change management and document control processes, quality auditing, root cause analysis, and problem-solving are highly desirable. Responsibilities: Administer the Change Management and Document Control system. Perform QA product release. Lead creation and modification updates for SOPs, work instructions, and other quality documentation. Review quality records for completeness and compliance with QSR and ISO requirements. Assist Quality Management with various projects, as required Support the eQMS electronic documentation system, as needed Conduct, participate and support internal quality audits, process/product improvement projects, and disposition activities Participates in FDA inspections and customer audits Perform other relevant duties as may be assigned by management. Skills and Abilities: Analytical decision-making skills to apply logical or scientific thinking principles to a wide range of intellectual and practical problems. Good knowledge and skills in using advanced personal computer productivity programs for word processing, spreadsheets, database manipulations, and flow charts. Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations. Good written and verbal communication skills. Interpersonal skills to interface with all levels of the organization, management, customers, and suppliers. Lead Auditor certification Experience in the medical device or diagnostic industry, a plus. 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 report

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