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REMOTE WORK FROM HOME Seeking experienced for to develop and design proprietary Personal Lines & Personal Auto Product forms and monitor, analyze and implement ISO products. REMOTE WORK FROM HOME Seeking experienced for to develop and design proprietary Personal Lines & Personal Auto Product forms and monitor, analyze and implement ISO products.
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For more information, visit The Maximus Analyst (ISSO) will work directly with the Maximus ISO Federal Director to identify and manage implementation of security policies, standards, and procedures that support customers with federal requirements to include FISMA, applicable FAR Clauses, Executive Orders, and OMB's specific to systems assigned.
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Liaising with the facility manager to ensure that our operations adhere to our ISO obligations in terms of traceability, quality documentation, training, and calibration records. Providing the team with clear instructions on machine maintenance and managing a third-party support network for any necessary repairs or equipment.
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Medical device development experience with thorough understanding of Design Control guidelines as defined by FDA, MDR, ISO, CSI, and other standards. Expertise in analog and digital circuit design and layout using tools like Altium Schematic Capture.
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Experience with Software Quality Control under IEC, ISO, UL, DO-178C, or any other formal software management systems. Experience in an Agile/Scrum environment (Atlassian, JIRA/Confluence, etc.
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Understanding and knowledge of the ISO/OSI model at L1-L2 levels, as well as IPv6, TCP, and UDP protocols. Understanding and knowledge of the ISO/OSI model at L1-L2 levels, as well as IPv6, TCP, and UDP protocols.
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Familiarity with ISO, FDA, and GMP requirements related to the Value Streams ability to produce and control product(s) and material(s). Maintains and follows established BSR, SOP procedures for GMP, ISO, FDA compliance.
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Extensive knowledge of ISO and CMMI quality standards and ability to ensure program adherence. Agile certification required (PMI-Agile Certified Practitioner (PMI-ACP), AgilePM Foundation, ICAgile Certified Professional (ICP), Certified Scrum Master, SAFe Agilist, etc.
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Only QUALIFIED Healthcare Professionals accepted)
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DescriptionThey key responsbilities of the Quality Manager will be:Quality Management Systems (QMS):Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with ISO standards and other relevant regulations.
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Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulations. Ensure compliance with all FDA, customer, and Paragon Medical reporting requirements (Device Master Records and Device History Records.
$100,000 a yearFull-timeExpandUpdated 14 days ago
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