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Quality Assurance Associate Job Locations US-WA-Bothell ID 2024-16368

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1 Job Function Quality & Regulatory Overview 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). Responsibilities 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/ISO 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 is a plus 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. Qualifications 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. 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, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more. Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disa