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Fluxus Inc. is seeking a highly motivated Quality Engineer with broad experience in quality systems, manufacturing, testing and IQC operations within the biotech industry. He/She will be part of an interdisciplinary team and will play a key role in the development, execution, and implementation of new production lines, support product transfers into manufacturing, production scale-up, Incoming Quality Control, process development and supplier performance activities related to a novel diagnostics platform. Specific skills include: QC Manufacturing Experience Development of standardized test methods, Gage R+Rs, DOEs, engineering and clinical builds. Oversees manufacturing QC testing and leads test method improvement activities. Maintains ASL, conducts vendor audits and provides feedback to suppliers. Coordinates Internal Audits to maintain compliance to ISO 13485 and 21 CFR Part 820. Responsibilities include but are not limited to the following: Quality representative overseeing IQC and QC Will oversee ASL (approved supplier list) Responsible for configuring and reviewing DOEs, protocols, process validations, performing data analysis, drawing conclusions, and communicating results. Support activities related to medical device manufacturing. Implementation and maintenance of the quality management system Minimum Education and Experience Requirements: BS degree with a minimum of 2-3 years of experience in medical device manufacturing and product development. Must have strong knowledge of medical device/IVD standards applicable to 21 CFR Part 820 and ISO13485 requirements. Superior time management, ability to work on several projects simultaneously, strong statistical skills. Excellent presentation and written/verbal communication skills. Experience working in a fast paced, small startup environment. Other beneficial skill sets: Experience with Microview and Keyence inspection systems Experience developing Quality Inspection Plans Experience with QMS system using Greenlight Guru Experience in Statistical Analysis/DOE using Minitab Experience using Jira, NetSuite Experience training to ISO/QSR About Fluxus: Fluxus Inc. is a privately held development-stage medical device company located in Sunnyvale, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare. As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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