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Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA); American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; Medical Device Single Audit Program (MDSAP); and other regulatory jurisdictions, as applicable, to help the company lead the Medical Device and Biologics industries in quality practice.
$45,000 - $60,000 a yearFull-timeExpandUpdated 6 days ago - UpvoteDownvoteShare Job
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Immunology, Laboratory, biochemistry, glp, gmp, biology, elisa, antibodies, aseptic technique, iso 13485, Chemistry, assay development, assay. immunology, Laboratory, biochemistry, glp, gmp, biology, elisa, antibodies, aseptic technique, iso 13485, Chemistry, assay development, assay.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Validation, Validation protocols, Pq, Oq, Iq, Gmp, Process validation, Validation testing, Medical device, Equipment validation, Engineering, Quality assurance, Iso 13485, Method validation, Fda, Equipment qualification.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Quality engineering, Medical device, design control, risk assessment, risk management, Quality assurance, Root cause analysis, Capa, Quality control, Quality management, Iso 13485. Quality engineering, Medical device, design control, risk assessment, risk management, Quality assurance, Root cause analysis, Capa, Quality control, Quality management, Iso 13485.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Quality engineering, Root cause analysis, Capa, Iso 13485, Medical device, Audit, Quality management system, Quality assurance, Engineering. Quality engineering, Root cause analysis, Capa, Iso 13485, Medical device, Audit, Quality management system, Quality assurance, Engineering.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Troubleshooting, electro mechanical, Class II, iso 13485, scripting software, R&d, optic, soldering. Troubleshooting,electro mechanical,Class II,iso 13485. Troubleshooting, electro mechanical, Class II, iso 13485, scripting software, R&d, optic, soldering.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws, and standards.
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ISO - 13485 Quality Management System experience preferred. Experience working within a regulated Quality System (i.e. ISO, AS, GMP, etc.) Preferred experience working in thermoplastic injection molding and/or Swiss component manufacturing and/or CNC machining manufacturing.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Adhere to International Organization for Standardization (ISO) 13485 certification requirements. Adhere to International Organization for Standardization (ISO) 13485 certification requirements.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Central Plastics & Manufacturing is an ISO (9001, 13485 & AS9100) certified high quality plastic manufacturer located in Tracy, Northern California. The Quality Inspector is responsible for in-house inspection of plastic injection molded parts being manufactured.
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Understanding of FDA regulations including (ISO) 13485. Understanding of FDA regulations including (ISO) 13485. Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution.
$70 - $75 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Overseeing Vigilance and Post-Market Surveillance activities. In charge of HIPArelated activities, including Privacy Officer training for associates on updated and enhanced quality system procedures and instructions.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Acting as the ISO and 13485, and FDA Regulatory Management Representative. Adept at utilizing statistical tools like DOE, Cp/CPK, Gauge R&R, FEMA, SPC, and PPAP to analyze data, identify root causes, and optimize processes.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Quality assurance, Compliance, GMP, Document control, Batch Record, Batch Record Review, product release, investigations, Root cause analysis, iso 13485, audit, quality compliance. Knowledge of GMP, FDA, ISO requirements.
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Exposure to ISO: 9001 2015 and 13485 2016. Working experience with ISO: 14644 and 14698. Your role as an NPI (New Product Introduction) Quality Engineer will allow you to serve staff and leaders and help provide creative solutions to drive CPC's short- and long-term goals.
ExpandApply NowActive JobUpdated 3 days ago
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