- Compass Group, North America (Aurora, CO)
- …results-driven culture Compliance & Incident Response * Ensure adherence to OSHA, FDA , USDA, EPA and other regulations * Investigate incidents and develop Corrective ... credentials preferred. * 5-10 years experience in manufacturing preferred focus on FDA regulated production * Strong analytical and investigative skills * Knowledge… more
- Globus Medical, Inc. (Eagleville, PA)
- …others + Monitors compliance within company policies and procedures (eg, compliance with FDA , ISO 13485, or other regulations). + Complies with all safety and health ... in a supervisory capacity + Demonstrated knowledge of ISO and quality systems as FDA and OSHA requirements, as a plus + Experience analyzing and presenting detailed… more
- Globus Medical, Inc. (Eagleville, PA)
- …requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... ability to understand and comply with applicable Food & Drug Administration ( FDA ) regulations and Company operating procedures, processes, policies, and rules is… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with raw materials or testing of raw materials that are included in FDA approved products/processes as well as with internal USP staff globally including: Program ... new monographs, modernization of existing monographs, and compendial requests to address FDA comments on proposed monographs to the USP-NF. + Develops specific plans… more
- Danaher Corporation (Chaska, MN)
- …engineering drawings, work orders, and other specifications while maintaining FDA requirements. Travel, Motor Vehicle Record & Physical/Environment Requirements: + ... previous experience in: + Experience in a regulated industry preferred (eg, FDA , ISO). + Proficiency with Microsoft applications, including Word, PowerPoint, and… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Holland, MI)
- …Essential Duties and Responsibilities + Assist in troubleshooting with USDA-FSIS and FDA regulatory issues and food safety or quality deviations. + Provide support ... on that data. + Must be able to read and interpret FSIS and FDA regulations and required certification codes. Certificates, Licenses and Registration + Should be… more
- Kerry (Vesper, WI)
- …Develop, review and align procedures with Kerry global standards and FDA /CFIA expectations. Internally audit against global and regional standards and site ... and regulatory audit compliance. Support the site for regulatory inspections ( FDA /CFIA), identify preserved (ie.organic, Kosher) and customer audits. + Quality… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …scheduling, vendor oversight) is a plus. + Familiarity with regulatory requirements ( FDA , EMA, OSHA, DEC) and quality systems (change control, investigations, CAPA) ... regulations, quality systems (change control, investigations, CAPA), and applicable standards ( FDA , EMA, OSHA, DEC). + Project Management Skills: ability to manage… more
- Hologic (Newark, DE)
- …Utilize phase/gate processes to execute programs in alignment with **ISO** and ** FDA regulations** , ensuring adherence to design control procedures and quality ... design cycles, and industry standards. + In-depth understanding of **ISO** and ** FDA regulations** , including design control procedures. + Expertise in risk… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Innovation & Continuous Improvement** + Identify emerging technologies and ... familiarity with robotics, sensors, and real-time control systems are preferred + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance. + Knowledge of… more
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