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Experience in Device Quality System, Design, Manufacturing and Testing, 21 CFR Part 820, DHF, DHR, DMR, and overall Device Regulations, CDRH and 510 k or PMA approvals are a plus. Review CDMO/CMO manufacturing services agreements, support quality agreements, RFP.
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Experience in Aseptic Product Manufacturing, Transdermal Patch Manufacturing or Solid Dosage Product Manufacturing for commercial products or late-stage clinical products is a must.
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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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Coordinate with manufacturing associates for the completion or correction of DHR errors. Completes batch record review at the final stage of the manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met.
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Supervises personnel responsible for incoming and final inspection as well as batch records (DHR) review. May serve as backup reviewer for DHR reviews. With an expertise in contract manufacturing, our in-house product design and mold making, accelerated tooling, and strong up-front engineering allows us to control and support programs at all levels.
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Submitting and maintaining test result documents Working directly with manufacturing and engineering personnel to test and inspect components and materials Promoting the smooth flow of products through quality control to disposition Providing test and inspection support to all new process developments Reviewing Device History Records (DHR) Reviewing all lab results and approve product release.
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Coordination with Manufacturing associates for completion/correction of DHR errors. Completes batch record review at final stage of the manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met.
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As the Operations Quality Specialist 2nd Shift , youll be responsible for quality support for manufacturing of FDA medical devices. Reviews documentation associated with a given product and performs Design History Record (DHR) approvals.
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Perform DHR Review of manufacturing performed while working on potential improvements to the overall documentation process. Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software such as Minitab or JMP.
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Prepares and assembles Device History Record(DHR) paperwork for use in the production of Finished. Utilizes communication skills to maximize CPS manufacturing production efficiency. Works with assembly supervisor to achieve requirements of daily work schedule for CPS production.
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Other duties assigned by manufacturing supervisor and or line leader. The Operator / Assembly is a temporary role on either Day or Swing Shift (Monday - Friday from 6:30am - 3pm or 2:30pm to 11pm) that is primarily responsible for supporting the manufacturing build and test of Company product.
$19 - $21 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing. Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
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DHR Review: Document review, SAP transfer review, variance review and submission to quality. The Bulk Formulations Chemist Lead will be supporting the Manufacturing Team at Grifols Diagnostics Solutions, located in San Diego, CA. This position is responsible for the manufacture of bulk clinical and commercial kit reagents.
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Develop, review, and approve inspection plans, DHR, and product drawings for new products. Recommend and provide statistical support and expertise and analytical problem solving for product development and manufacturing.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Follow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, and current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP) during all phases of packaging and labeling, storage, irradiating supplies, and cleaning.
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