Operations Quality Engineer II

3 weeks ago

Mill Creek, United States NanoString Full time

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. The Operations Quality Engineer II supports the quality system processes and activities associated with the manufacturing of NanoString products. The scope of this position includes quality engineering, support for design controls, supplier and incoming quality, risk management, and quality oversight over manufacturing processes. The Operations Quality Engineer II provides technical, quantitative, and coordination support to assure products and processes are designed, deployed, and operated according to requirements. Work scope of this position includes management of key processes relating to quality engineering tasks, ensure robust design controls, supplier quality, risk management, tech transfer to manufacturing operations and driving KPI affecting quality in manufacturing. This 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). In addition, this individual provides guidance to Manufacturing and Operations in navigating the NanoString Quality System. Requirements: BS in Life Science or Engineering discipline At least 3 years of experience in the medical device or biotechnology industry Experience with product development within a regulated industry Hands on experience with Quality Engineering tools such as; Risk Assessment (pFMEA), Root Cause Analysis (5 Whys, FTA, Ishikawa, Pareto, etc.), Process Flow Maps, etc. Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro molecular diagnostic manufacturing. Working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971,the EU MDD, CMDR, & IVDD Essential Responsibilities: Support Manufacturing and Operations in navigating the Quality System including SCARS, nonconformances, deviations, change requests, CAPAs, and validations. Monitor SCARS, nonconformances, deviations, complaints, and trends to identify and recommend corrective and / or preventive actions. Conduct root cause investigations and analyses of issues as assigned. Conduct risk assessments for SCARs, nonconformances, deviations, and document changes. Provide Quality leadership on process, test method, and equipment validations. Work with Supply Chain and suppliers to resolve raw material issues. Manage the review and approval of Molecular diagnostic &/or Instrument DHRs (Batch Records). Implement appropriate process monitoring and control methods consistent with the level of process/product risk using customer feedback. Support customer complaints investigations and supplier audits Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities Basic application of statistical tools and methods. Preferred Qualifications ASQ certified or CQE a plus Certified auditor a plus Experience providing Quality support of molecular diagnostics products

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