- Medtronic (Jacksonville, FL)
- …the application of design controls in product development and released product management . Responsibilities may include the following, and other duties may be ... plans against contractual and/or process requirements. + Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk … more
- Medtronic (Fridley, MN)
- …throughout the product lifecycle. This position supports Medtronic's Cardiac Rhythm Management (CRM) and Cardiac Ablation Solutions (CAS) Operating Units as part ... and CAS technologies across the product lifecycle, including risk management , complaint analysis, vigilance reporting, and clinical trial safety...medical device regulations, including FDA CFR 21, EU MDR, ISO 14971, ISO 14155, and ISO… more
- Ferguson Enterprises, LLC. (Glendale Heights, IL)
- …as needed. + Communicate quality related issues / concerns to the Quality Management Representative . + Effectively communicate and roll out all corporate ... and improve quality and safety programs to ensure compliance with all ISO , safety regulatory, and corporate requirements. **Responsibilities:** + In partnership with… more
- Integra LifeSciences (Braintree, MA)
- …testing activities. The role works with Product Development, Project Management , Regulatory, Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** ... or improved products in close collaboration with Product Development, Project Management , RA, Marketing and Medical Affairs. Support Design Reviews, Technical… more
- Integra LifeSciences (Princeton, NJ)
- …programs is preferred. The qualified candidate must understand the concepts of risk management as it relates to bacterial endotoxin monitoring in a medical device ... programs, ensuring compliance with relevant regulatory requirements such as ANSI/AAMI ST72, ISO 11737-3, USP <85>, USP <161>, and FDA guidelines. + Ensure proper… more
- Prysmian Group (Claremont, NC)
- …of US health and safety regulations (OSHA). + Knowledge and Experience with ISO Management Systems a plus. + Knowledge of worker's compensation regulations. ... and maintain certification to ISO 14001:2015 and ISO 45001:2018 Standards (Integrated Management System). +...Works closely with HSE counterparts and serves as Region representative to cross-regional forums for best practice sharing, idea… more
- ZOLL Medical Corporation (Pawtucket, RI)
- …in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971 * Develop and implement ... customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride...to medical device manufacturing + Working knowledge of EN ISO 13485, ISO 14971 and FDA QSR… more
- Prysmian Group (Indianapolis, IN)
- …+ Experience with Environmental permit compliance (Air and water permitting) and waste management + Knowledge of ISO Management Systems (ISO14001:2015 & ... minimize company exposure and ensure compliance with corporate HSE management system and all applicable HSE regulations (OSHA; EPA;...with Quality Manager to achieve and maintain certification to ISO 14001:2015 and ISO 45001:2018 Standards. +… more
- USA Donaldson Company Inc. (Stevens Point, WI)
- …to delineate operational procedures and responsibilities. + Fulfill role as Management Representative . + Actively participate in Accelerated Product Development ... system that maintains and improves product/process conformance to customer expectations and ISO 9000 quality system in a cost-effective manner. Ideal candidates will… more
- Katecho (Des Moines, IA)
- …improvement of the quality system through monitoring of production operations, personnel management , and adherence to and administration of ISO 13485 and ... systems. + Experience working with, or knowledge of, business management systems particularly ISO 13485 preferred, and...employees. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an… more
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