- Organon & Co. (Plymouth Meeting, PA)
- …global GMP Quality Systems and regulatory requirements. + Experience in medical device Quality Systems is preferred, including familiarity with ISO13485, ... and distributed in accordance with Organon expectations and all applicable regulatory requirements. The External Systems Quality Leader (ESQL) serves a leadership… more
- Jabil (West Chester, PA)
- …will support key quality systems, ensure compliance with internal and regulatory standards, and provide day-to-day engineering support to manufacturing operations. ... TIC, MIC, QIC). + Engage in internal/external audits and regulatory compliance activities. + Provide training and guidance to...Quality Engineering (eg, CQE) is a plus. Benefits + Medical , Dental, Prescription Drug, and Vision Insurance with HRA… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of experience with a Master's degree. + Minimum 8 years of medical device industry experience in a clinical capacity (clinical demonstration and education) with… more
- Globus Medical, Inc. (Audubon, PA)
- …engineering, process improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance, and quality ... Assurance** + Ensure all Globus products and processes meet regulatory and internal quality standards. + Review, improve, and...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- Fujifilm (Harrisburg, PA)
- …II + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and other Key Operators in the use of Fujifilm's Medical Informatics. The Senior Clinical Consultant, MI - I...business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... go-live.. Lead PE's must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Knowledge Base articles. + Maintains an expert working knowledge of current medical imaging products and related technologies. + Engineers must have the ability… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Cardiovascular opportunities. + Develops effective business partnerships with the Medical Informatics marketing team, Solutions Delivery and Support Department,… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... with Key Accounts and Opinion Leaders within the Liver/Hepatology Medical Oncology community. Manage specific assigned geographic areas and successfully… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... required. + Ability to work in a variety of work environments within medical facilities, including work sites under construction. + Ability to physically work in… more