• Cordis (Miami Lakes, FL)
    …process/equipment validation (IQ/OQ/PQ) and test method validation (TMV) per 21 CFR 820, ISO 13485, and ISO 14971; set sampling plans and acceptance criteria. ... experience. **Preferred Qualifications** + Proven track record working within ISO 13485 and FDA-regulated environments. + Experience with process/product validation,… more
    DirectEmployers Association (11/26/25)
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  • Caris Life Sciences (Phoenix, AZ)
    …laboratory, operational, and customer-facing functions to maintain compliance with FDA, ISO 13485, CAP, and CLIA standards while driving proactive identification of ... Caris' Quality System procedures and applicable external requirements (FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory frameworks). + Lead… more
    DirectEmployers Association (11/12/25)
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  • Integra LifeSciences (Plainsboro, NJ)
    …with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable regulatory agencies. **SUPERVISION RECEIVED** Under direct ... + Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements. + Responsible for reporting all discrepancies to the… more
    DirectEmployers Association (11/07/25)
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  • Powell Industries, Inc. (Houston, TX)
    …internal audit results and write final audit reports. - Coordinate Powell's ISO Certification Audits with a third party Certification Company. - Support the ... Powell's training system. - Read, interpret, and apply the ISO quality system standard. Minimum Qualifications - A minimum...Word, Excel, PowerPoint, Access, Visio. - Qualified as an ISO QA systems auditor. - Familiar with the ISO9001:2015… more
    DirectEmployers Association (11/05/25)
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  • Olympus Corporation of the Americas (Center Valley, PA)
    …and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations. + Develops ... audits. + Knowledge of regulators including but not limited to 21CFR820, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations. + Demonstrated ability to… more
    DirectEmployers Association (10/30/25)
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  • GCI Communication Corp (Juneau, AK)
    …relate them to appropriate security controls. o Experience with frameworks and standards, such as ISO 15489, ISO 9001:2008 (4.2.4), ISO 23081, ISO ... 27001/2, ITIL, COBIT, and NIST frameworks. o Experience with privacy and compliance standards, such as SOX, HIPAA and PCI-DSS o Knowledge of information security data and processes. o Excellent organizational, planning and time management skills. o Knowledge… more
    DirectEmployers Association (10/17/25)
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  • Battelle Memorial Institute (Columbus, OH)
    …managers, customers - to maintain complete, accurate records under an ISO 13485 compliant Quality Management System. **Responsibilities** + Manages project file ... medical device or closely related field. + Experience working under an ISO registered Quality Management System or related regulated environment in document control… more
    DirectEmployers Association (12/18/25)
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  • HP Inc. (Austin, TX)
    …organizations, and overall concepts of GRC, CMMC compliance, NIST CSF framework, ISO assessments; and assist with orchestrating evidence gathering, management of and ... Certification and readiness for critical assurance frameworks such as ** ISO /IEC 27001** , **CMMC Levels 1 & 2** ,...grasp of control frameworks such as NIST CSF, COBIT, ISO /IEC 27001, SOC 2, PCI DSS, HIPAA, and SOX.… more
    DirectEmployers Association (12/16/25)
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  • ENTRUST Solutions Group (Owings Mills, MD)
    …billing concerns. + **Compliance and Process Improvement:** Ensure adherence to ISO standards, HR, safety, and company policies. Continuously enhance employee, ... client, and operational experiences. Enforce ISO compliance through accountability and training. + **Cross-Functional Collaboration:** Partner with centrally managed… more
    DirectEmployers Association (12/11/25)
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  • AeroVironment (Albuquerque, NM)
    …System (QMS) across the organization. This role ensures compliance with ISO , AS9100, customer, and regulatory standards. Additionally, this role will spearhead ... Management System (QMS) implementation, communication, monitoring, ensuring compliance to ISO , AS9100, customer, and regulatory requirements. + Define and deploy… more
    DirectEmployers Association (11/29/25)
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