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Sr. QA Analyst/Doc Control Specialist

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Location: San Francisco Bay Area - East Bay

Purpose of Role:
AVERAGE DAY: Document Control o Process DCOs with no errors o Maintain Document Control files (master documents, electronic files, standards) o Maintain logs and update CAPA, Complaints and other Quality System files o Ensure proper upkeep of technical documents o Maintain external standards Maintain Training Records/files. Ensure training requirements for all employees are defined and met Quality System o Support Internal Audit program and provide trending data for Management Review o Support CAPA program and provide trending data for Management Review o Support complaints process with intake, timely closures. Provide trending data for Management Review o Ensure all quality issues are communicated in a timely manner o Participate in Management Review (gathering metrics, creating charts and providing information). o Provide back-end support during eternal audits Maintain calibration / tooling logs. Ensure on time calibration/PM of equipment. Maintain interface with outside calibration firm Maintain supplier files MUST HAVES: Good understanding of FDA, ISO requirements for medical devices Must be detail orientated, well organized and have excellent communication skills Must be able to accomplish objectives with minimal supervision Ability to read and understand blueprints, drawings, and other documented specifications EXTRA AWESOME Bachelors of Science, preferably in life sciences or equivalent work experience Strong Excel skills (VLOOKUP, macros etc.) 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