- Geisinger (Danville, PA)
- …+ Supports inspections/audits from regulatory/recommending bodies including TJC, PA DEP, FDA , ACR, and DOH. + Supports/oversees use of advanced medical imaging ... software including but not limited to patient dose tracking...Radiology (ACR) and United States Food and Drug Administration ( FDA ) definition of a qualified medical physicist (QMP). Certification… more
- System One (Pittsburgh, PA)
- …+ Ensure all statistical work complies with relevant regulatory guidelines (eg, FDA , EMA) and Good Clinical Practices (GCP). + Use statistical software ... knowledge of clinical trial design, statistical methods, and regulatory requirements ( FDA , EMA). + Experience with developing statistical analysis plans (SAPs) and… more
- Cook Medical (Pittsburgh, PA)
- …and data mapping documents, and commissioning documents (ie unit tests, software verification tests).* Support the delivery of applications and/or business ... for SOPs.* Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.* Coordinate activities with external… more
- Envista Holdings Corporation (Quakertown, PA)
- …the leading manufacturer and distributor of innovative dental imaging equipment, software , and solutions. We offer meaningful work through innovation, diverse ... hub for the design and manufacturing of leading dental imaging devices and software . The facility has a growing, energetic, and diverse mix of professionals spanning… more
- Fujifilm (Harrisburg, PA)
- …trends, best practices, regulations, and a wide range of hardware and software products. This position requires interaction with sales, technical support, field ... point of contact between Engineering and Integration for new products, software changes including testing, and new information dissemination. Responsible in… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Sysco (Harmony, PA)
- …order loading, product stocking and replenishment, night operations equipment and software inventory maintenance and repair; ensuring safety and security of night ... Complies with local, state and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **QUALIFICATIONS** **Education** + High school diploma or general… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... + Designing and developing instruments and implants using Pro/E software + Partnering with in-house prototype shop and outside...for rapid prototyping and evaluation + Proficiency in Pro/E software for design and drafting + Well organized, detail… more
- Sanofi Group (Swiftwater, PA)
- …tools and measuring equipment + Ability to use and navigate windows software Must have proven experience in hands-on programming and configuration of Programmable ... Acquisition (SCADA) such as the following manufacturers hardware and software products: Hardware: + Rockwell: PLCs, Panelview OITs +...Familiar with local and federal code requirements such as FDA CFR, NFPA/ NEC, OSHA, DEP, EPA and industry… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... in Healthcare / Radiology Informatics product marketing. + Extensive experience in software promotion. + Extensive experience managing software product roadmaps… more