- KBR (Norfolk, VA)
- Title Lead ISO 9001:2015 Auditor Belong, Connect, Grow, with KBR! Program Summary The Marine Corps Prepositioning Program (MCPP) is based in Jacksonville, Florida. ... by documenting audit tests and findings. You will maintain and ensure an ISO compliant library and assist with all commodities document libraries. You will assist… more
- Plastipak Packaging, Inc. (Champaign, IL)
- Job Description As an ISO and Food Safety Leader, you will ensure that the processes needed for the quality management system are established, implemented, and ... offer job stability through market uncertainty You Will Function within the ISO /Team environment to ensure ISO /BOS compliance. Oversee the development,… more
- Robert Half (Columbia, MD)
- …about information security and compliance? A national leading consulting firm is seeking an ISO Lead Certified Senior Manager to take a pivotal role in their Risk ... team dedicated to providing top-tier advisory and attestation services for ISO 27001 compliance, helping clients streamline their processes, strengthen their… more
- UL, LLC (Northbrook, IL)
- …seeking compliance to standards in functional safety and related fields, including IEC 61508, ISO 13849, IEC/EN 62061, UL991, UL1998, ISO 61511, ISO 21448, ... to standards in functional safety and related fields, including IEC 61508, ISO 13849, IEC/EN 62061, UL991, UL1998, ISO 61511, ISO 21448, UL 4600, IEC 61487, … more
- Integra LifeSciences (Princeton, NJ)
- …and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, ISO 14644, ISO 14698, BS ... EN 17141, EU GMP Annex 1, ISO 11135, ISO 11764, ANSI/AAMI ST98, ISO 11137, ISO 11737-1/2/3, ISO 11765, ISO 11138, ANSI/AAMI ST 72and USP. Support… more
- Aptyx (Charlotte, NC)
- …testing, and interpret performance data. Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR 820. Familiarity with relevant ... device specific standards such as ISO 10555, ISO 11070, ISO 5840, ISO 25539, and others. Strong problem solving skills with clear and concise technical… more
- PPL Corporation (Allentown, PA)
- …Transmission Operations personnel. Ensure internal compliance with FERC, NERC, PJM, ISO -NE, and PPL requirements. Monitor training methods and requirements at peer ... execute individually tailored training sessions using the simulator to maintain ISO -NE/PJM/NERC certification skill levels for all TSOs. Support the development and… more
- Oracle (Madison, WI)
- …healthcare solutions align with global medical device standards, including IEC 62304, IEC 82304, ISO 13485, ISO 14971 , and related IMDRF SaMD guidance. You will ... Regulatory, and Clinical teams to ensure product development conforms to ISO 13485 , ISO 14971 , EU MDR/IVDR expectations, and IMDRF SaMD risk frameworks.… more
- Meta (Providence, RI)
- …insights Certifications in Maintenance & Reliability such as CMRP, CRL, CRE Knowledgeable of relevant ISO standards ( ISO 14224, ISO 17359, ISO 55000) ... in Maintenance & Reliability such as CMRP, CRL, CRE Knowledgeable of relevant ISO standards ( ISO 14224, ISO 17359, ISO 55000) Public Compensation:… more
- Merck & Co. (Rahway, NJ)
- …and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971). - This position will interact with cross-functional ... device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971) Collaborate with cross-function teams to improve processes related to… more
- Integra LifeSciences (Plainsboro, NJ)
- …and implementation of new and updated Quality System procedures for ISO /QSR, such as validation protocols, manufacturing procedures, product & material ... compliance with corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device… more
- Takeda Pharmaceuticals (Lexington, MA)
- …continuously improving our global EHS Management System. You will ensure alignment with ISO 14001 and ISO 45001 standards, simplify and standardize processes ... subject matter expert for corporate EHS management systems, ensuring alignment with ISO 14001, ISO 45001, and internal requirements. Lead the development,… more
- Kelly Services (Braintree, MA)
- …testing: bioburden, endotoxin, growth promotion, TOC & conductivity. Perform environmental monitoring in ISO 7 & 8 cleanrooms ( ISO 5 experience a plus!). Collect ... in Microsoft Office Suite (Excel, Word, PowerPoint). Familiarity with FDA and/or ISO quality standards ( ISO 13485 preferred). Ability to follow instructions… more
- Zimmer Biomet (Englewood, CO)
- …teams on compliance with design control requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO /EN standards Participate in risk ... management activities in compliance with ISO 14971 as expressed in the company's Quality Management...Accurately represent quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.) Other duties as assigned Your… more
- Takeda Pharmaceuticals (Lexington, MA)
- …with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). Act as or designate the Device ... and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP, and global quality systems. Strong background in… more
- Oracle (Columbus, OH)
- …is responsible for Interpreting and translating healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) ... limited to Interpret and translate healthcare software regulations/standards (IEC 62304, ISO 14971, ISO 13485, 21 CFR 820/11, etc. as applicable) into concrete… more
- Hologic (Marlborough, MA)
- …and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in a ... Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory… more
- Zimmer Biomet (Austin, TX)
- …validation, verification, regression testing, and cybersecurity to ensure compliance with FDA, ISO 13485, IEC 62304, and ISO 14971 standards. Monogram's ... medical device systems, ensuring compliance with applicable FDA and ISO regulations You will develop and maintain software validation...of relevant regulations and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and… more
- J&J Family of Companies (Santa Clara, CA)
- …and post-market surveillance is required. Successful history leading FDA inspections, ISO certification audits, and MDSAP assessments, with a strong understanding of ... global regulatory requirements. Proficiency in 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, ISO 27001, and EU MDR compliance… more
- GE HealthCare (Waukesha, WI)
- …Evaluate AI governance practices and alignment with leading guidance (eg, NIST AI RMF, ISO /IEC 42001, ISO /IEC 23894) and GE HealthCare policies. Support the Data ... 800-115, NIST 800-53, NIST 800-171, NIST Privacy Framework, NIST AI RMF, CSA CCM, ISO 27001, ISO /IEC 42001, and ISO /IEC 23894, ITIL v3, COBIT and FAIR is… more
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