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Quality Engineer

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Location: San Francisco Bay Area - East Bay

Purpose of Role:
AVERAGE DAY: • Be the main point of contact for day-to-day oversight of the CM from a o quality engineering, o process compliance and o quality system compliance • Ensure accurate and compliant deployment of changes (DCOs) o Make sure all aspects of a DCO is appropriately executed at the CM o Product disposition, Training and Certification, Document Control on the line etc. o Perform “First Article” inspection of product to ensure implemented changes are in effect • Assist the Company ME with training and certification activities at CM • Be the technical “canary in the coal mine” for the Company to provide us leading indicators of issues in production • Assist CM in performing accurate trending of production metrics • Perform audit of production line and critical component suppliers • Generate, manage and drive to closure SCARs opened for CM and critical suppliers • Manage/Support critical Quality System functions internally as we grow: o CAPA, Complaint management and trending o NCMR management o Internal Audit • Function as backup to Document Control, as needed MUST HAVES: • 5+ years related experience in a fast-paced medical device, start-up environment • Bachelor’s Degree in an engineering discipline • Knowledge of US FDA regulations, ISO Standards, and GMP's • Demonstrated ability to communicate and work collaboratively across functions, including engineering and product groups EXTRA AWESOME • Lean and/or Six Sigma experience a plus • Experience in technical project/program leadership and management • Analytical skills PHYSICAL REQUIREMENTS • Ability to sit, stand, and/or walk for no less than 8 hours a day • Ability to lift a minimum of 25 pounds Qualified candidates please reply to: Cindy Johnson tel: 925-577-8135

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Chozen, Inc. 21001 San Ramon Valley Blvd., Suite A4-147, San Ramon, CA 94583  T: 925.242.1010 F: 925.886.8600