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Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO, QSR, and FDA regulations. Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO, QSR, and FDA regulations.
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A Bachelor’s or Associate degree is a plusMinimum 3 years supervisory experience; 5 years of experience in a production environmentBasic PC skills including Microsoft Office, specifically Microsoft Excel and PowerPointExperience in material control, production control and quality control processesExperience working in the medical device industry (ISO, GMP, FDA, QSR, etc.
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Issues reports and documentation in accordance with established procedures on a variety of quality system programs related to QSR (CGMP) and ISO requirements. + Ability to understand and follow FDA regulations, ISO requirements, and BD Quality Systems.
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Working knowledge of FDA, cGMPs/QSR, and ISO quality system requirements. Demonstrates commitment to the development, implementation, and effectiveness of Quality Management Systems per ISO, FDA, and other regulatory agencies.
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Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements. Follow engineering drawings, work order information, SOPs, and other written and verbal specifications in the manufacturing process while maintaining FDA requirements.
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations. Analytical chemistry instrumentation experience (e.g. HPLC, pH, KF, AA, GFAA, titrations, etc.
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Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. The position of Manufacturing Line Quality Engineer is within our Infectious Disease Developed Markets business unit located at Westbrook, Maine.
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Demonstrate commitment to the development, implementation, and effectiveness of Sekisui Diagnostics' Quality Management System per ISO, FDA, and other regulatory agencies. Understand and adhere to all QSR, ISO, Safety, and Legal requirements.
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Ensure accuracy and completeness of all procedures and instructions related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, FAA, QSR, ISO, Good Manufacturing Practices, manufacturing exception events (MEEs), and other client policies and procedures.
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May perform soldering, fabricating, crimping, mechanical assembly, sealing, ultra-sonic welding, bonding and gluing with adhesives, Epoxy or RTV. Kitting assemblies using a parts list, scanner and inventory software as required.
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Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements. Assist in maintaining ISO and FDA QSR quality systems compliance.
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Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations. Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques.
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Proficiency with FDA QSR/cGMP and ISO13485 requirements to maintain commitment to environmental and quality regulations and knowledge of process characterization and process validation utilizing Statistical tools, DOE, DFSS etc.
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Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR). Experience in an FDA environment preferred. Prior knowledge of MES, SPC, or SAP a plus.
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Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines), and ensure compliance with testing SOPs and specifications. Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines), and ensure compliance with testing SOPs and specifications.
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