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Such records and reports include, but are not limited to, timekeeping, projects, traffic control, traffic delays, major incidents, highway damage, highway spills, major incidents, hazardous waste, hazardous materials, personnel evaluations, materials, purchases, fuel, equipment, stormwater, and any other report or record as requested.
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This will include DHR review, NCR and CAPA generation, processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review.
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Perform records coordinator activities in support of quality record retention on-site and off-site according to quality system procedures. Coordinate with manufacturing associates for the completion or correction of DHR errors.
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Maintain accurate records to ensure Device History Records (DHR) and quality documents are accurate when required. Basic understanding and use of a multimeter, DC power supplies, Loctite/EFD dispensing units, and machine shop equipment (Milling and Lathe.
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Based in San Clemente, CA, you will be responsible for building and preparing components, subassemblies, and top-level assemblies, complete documentation and data input into an MRP system and/or Batch Records (BRs) and Device History Record (DHR.
$31,000 - $40,300Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position will assist with the development, implementation, and monitoring of the Quality Management System (QMS) to include the Corrective and Preventive Action (CAPA) System, Design Control, Change Control and Records Control, Document Control, Training Records, Device History Records (DHR) and various other elements within the quality systems as it relates to regulatory compliance and Erbe Quality Systems.
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Insures proper handling of hard copy file Device History Records (DHR) and associated changes related to CPS manufacturing. Works with Assembly Supervisor to develop daily work schedule for CPS production requirements.
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Generates assembly records for system Device History Records (DHR) The Production Technician is responsible for assembling electro-mechanical medical devices in compliance with applicable FDA, state, OSHA, and ISO regulations and standards, for ensuring that capital equipment manufacturing issues are triaged and resolved.
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Perform device History Records (DHR) / batch records review for product release. 1 or more years of experience reviewing Batch Records or DHR' (or similar documents) a must.
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Review all Device History Records (DHR) and approve prior to product release. For document control, maintain all records within the QMS, route engineering change orders and other records for appropriate approvals.
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Performs Device History Records (DHR) review and "Release to Branch Plant" function including document verification and recording incoming inspection inventory. Records and other Quality System documentation.
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Perform Product Record Review (paper record review) of non-return complaints (DHR, Risk, Labeling, and other records) Familiarity with FDA regulations related to medical devices including DHR, GDP, GMP, Complaint Handling, etc.
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Perform DHR review and sign off to ensure records are reviewed and complete prior to release of product. Assist to onboard new Quality Technician I as needed. Working Knowledge of Statistical Process Control (SPC) tools and techniques and Gauge Repeatability and Reproducibility (Gauge R&R.
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The Quality Control Inspector will review device history records & document their work on the DHR. Inspect components utilizing inspection equipment. Utilize electronic systems to maintain training records.
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Lead the Device History Records (DHR) review and approval process. Lead nonconformance reports (NCR) and CAPA investigations. Performing statistical data analysis using Minitab or equivalent.
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