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Quality Systems Specialist II Job Locations US-WA-Bothell ID 2024-16367 Job Function Quality & Regulatory Overview The Quality Systems Specialist II is responsible for supporting elements of NanoString's Quality Management System (QMS). These QMS elements include, but are not limited to, Document Change Control processes, assigning and monitoring compliance for employee training, Quality System training across the organization, and management of regional and international standards that apply to NanoString's products, processes, and services. This role will ensure consistent implementation and improvement of the QMS and drive compliance to the QMS and ISO 9001 throughout the organization Responsibilities Responsibilities Oversee the Change Management processes and serve as an subject matter expert (SME) on document change processes. Chair Change Control Board (CCB) meetings, identify and implement improvements to the change process, track and report system performance, and usher changes to completion and implementation. Manage training for the NanoString system including: Collaborate with functional area leaders to identify training needs for all departments Assign training when new procedures are implemented Train and support people managers in monitoring training compliance Track training compliance and identify and implement improvements Develop and implement training and training tools for the Quality System to be used by all employees. Manage the monitoring and distribution of national and international standards that are applicable to our business. Monitor for updates to existing standards In collaboration with Regulatory, ensure completion of gap assessments when standards change. Work with Regulatory on identifying and implementing new standards Acquire requested standards and deliver to requestor Support the eQMS electronic documentation system, as needed Participate in ISO inspections and customer audits as a remote contributor Perform other relevant duties as may be assigned by management. Maintain frequent and regular communication with Manager on current activities, including priorities, progress, completions, and roadblocks. 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 9001 quality system standard. Good written and verbal communication with all levels of the organization, management, customers, and suppliers. Experience in the medical device, diagnostic, or the biotechnology industries is a plus Qualifications Qualifications Minimum Education: Bachelor's degree in a related field strongly preferred. Minimum Experience : 3-5 years quality-related experience in the biotech, pharmaceutical, and/or device industries. At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $$62,000 and $85,000 provides an opportunity to progress as you grow and develop within a role.The base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, shor