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We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults.
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This position works with the department team lead(s) and manager and with other technicians at the research and development or production and processing level to help ensure that Xtant Medical complies with and meets the standards of the Food and Drug Administration (FDA), American Association of Tissue Banks (AATB), International Organization of Standardization (ISO) 13485, and other regulatory agencies as necessary.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians. May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification/ validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensuring appropriate device history record (DHR) documentation. Working knowledge of FDA, cGMPs/QSR, and ISO quality system requirements.
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5+ years of electromechanical manufacturing management experience in an FDA regulated environment required, IVD experience strongly preferred. Regularly review paper based Device History Records (DHR) before product release.
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Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired. This person will collaborate with manufacturing sites and TPMs to access DHR records to perform DHR review.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Familiarity with FDA regulations related to medical devices including DHR, GDP, GMP, Complaint Handling, etc. Perform Product Record Review (paper record review) of non-return complaints (DHR, Risk, Labeling, and other records.
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Ensure appropriate device history record (DHR) documentation. Quality Management System per ISO, FDA, and other regulatory agencies. The position of Manufacturing Line Quality Engineer is within our Infectious Disease.
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Maintain accurate records to ensure DHR and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products. Experience in GMP, ISO, and FDA controlled environments preferred.
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Support production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
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Assist with review of DHR and final acceptance and release. Support company goals and objectives, policies and procedures, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and FDA regulations.
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Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience. At Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
$30 - $42 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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. Experience in FDA pre-approval inspections and GMP inspections is a plus.
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Support for product quality assurance, process improvements and all quality system program at. Responsible for exhibiting professional behavior with both internal/external business. occur in their area of responsibility, including product design, verification and.
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Demonstrates commitment to the development, implementation, and effectiveness of Quality Management Systems per ISO, FDA, and other regulatory agencies. The position of Manufacturing Line Quality Engineer is within the Infectious Disease Developed Markets business unit located in Westbrook, Maine.
ExpandApply NowActive JobUpdated 6 days ago
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