- Omnicell (Cranberry Township, PA)
- … Quality Engineer** Omnicell is seeking a **Staff Quality Engineer** that will report into a Manager or Sr. Manager of Product Quality **.** The Product ... required for efficient quality support of software development. + Liaise with Regulatory and other Quality departments throughout the product development process… more
- Cardinal Health (Sharon Hill, PA)
- …with all regulatory standards including EHS, cGMP, Radiation Safety, applicable FDA and pharmacy laws, DOT, and internal policies and interpretations + Manages ... sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis,… more
- Omnicell (Cranberry Township, PA)
- … Quality Engineer** Omnicelli s seeking a Senior Quality Engineer that will report into a Manager or Sr. Manager of Product Quality. The Product Quality ... including system engineering strategies and software interfaces. + Liaise with Regulatory and other Quality departments throughout the product development… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …CFR Part 803, 806, 820) + Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) + Corrective ... all medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You… more
- Wacker Chemical (Allentown, PA)
- …the QMS. + Regulatory & Documentation: + Ensure compliance with applicable regulatory requirements ( FDA , EU MDR, etc.). + Oversee document control systems ... for ensuring that all processes, documentation, and operations meet regulatory and quality requirements for medical device manufacturing and distribution.… more
- University of Pennsylvania (Philadelphia, PA)
- …issues. Identify operational barriers and escalate items requiring medical or regulatory decision-making. + Coordinate investigational product or device ... requirements; scheduling and conducting research visits in clinic; maintaining regulatory files; and preparing submissions to the Penn Biomedical Institutional… more
- BioFire Diagnostics, LLC. (Philadelphia, PA)
- …(pharmaceutical, cosmetic, food industries) Experience in participation in the management of regulatory audits (ie ISO 9001,ISO 13485, FDA , etc.). + Manage ... Post Market Quality team will be fully involved in managing quality processes during product development as well as during the product lifecycle. Primary Duties:… more
- Globus Medical, Inc. (Eagleville, PA)
- …to, supervising all operators and engineers. This individual works with the site manager and all engineers and operators to ensure the manufacture of high-quality ... products and to facilitate compliance with regulatory requirements. **Essential Functions** **:** + Overseas operations efficiency...Directly responsible for the production and quality of the product , as well as line personnel + Analyzes and… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... to: customer facing course material, instructional "how to" videos, product simulations, etc. + Responsible for executing all aspects...in the event of Senior II, Lead SSAT and manager absence. + Maintain close contact with customers for… more
- University of Pennsylvania (Philadelphia, PA)
- …meetings and will be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible for accurate data collection ... well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure… more