- 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
- ThermoFisher Scientific (Allentown, PA)
- …label layouts + Craft and approve serialization labels using Codesoft labeling software + Lead testing for serialization equipment and system connectivity + Maintain ... Chain Security Act), HDA (Healthcare Distribution Alliance) compliance (GS1 and FDA guideline support), and other serialized market regulations + Experience with… more
- GE HealthCare (State College, PA)
- …decisions. With our Active imaging platforms, procedure-based transducer portfolio, and software packages created for the end-user, we provide the solution to ... instruments (micrometers, calipers, CMMs). + Maintain documentation in compliance with FDA , ISO 13485, and GMP standards. + Collaborate with quality assurance… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... + Designing and developing instruments and implants using Pro/E software + Working with in-house prototype shop and outside...in lieu of a degree + Proficiency in Pro/E software for design and drafting required + Demonstrated self-starting… more
- Sanofi Group (Swiftwater, PA)
- …activities. As such, they may interact with representatives of Regulatory Agencies ( FDA , MHRA, PMDA, NMPA, ANSM, EMA, etc.). **ACCOUNTABILITY** The position reports ... to the clinical domain + Good working knowledge of standard computer office software + Excellent communication skills (oral and written) **Knowledge and Skills:** +… more
- Fujifilm (Harrisburg, PA)
- …Technical Assistance Center (TAC). + Participate in Clinical Validations Testing for each software release of the product to further enhance the overall accuracy of ... with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard...+ Proven experience in related field. + Healthcare or software application or IT industry background a plus. +… 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 ... design and manufacturing of leading dental imaging devices and software . The facility has a growing, energetic, and diverse...+ Experience working with medical devices. + Knowledge of FDA & ISO standards. + Experience working in a… more
- Teva Pharmaceuticals (West Chester, PA)
- …and storage devices. * Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that ... system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well...laboratory technical configurations * Knowledge of installation of system software and tools * Knowledge of workflows in the… more
- Honeywell (Pottsville, PA)
- …and flexible formats. Advanced experience with Solid Works design software desired. + Experience designing, developing, and managing testing methodologies ... drug product registration process including ICH stability guidelines. Familiarity with FDA , EMEA & Japanese Regulatory requirements relating to package design and… more
- ThermoFisher Scientific (Collegeville, PA)
- …in completing scripts/methods.** **Uses advanced troubleshooting skills (hardware and/or software ) to solve complex problems** **Program scripts with high complexity ... understanding of GxP requirements, SOPs, ICH guidelines, USP requirements and FDA ** **Proven troubleshooting and critical thinking skills** **Proficient in complex… more