- University of Pennsylvania (Philadelphia, PA)
- …trials. Participate in the conduct of audits by study sponsors, CROs, the FDA , the University of Pennsylvania's CTSRMC, and other groups. + Develop and maintain ... + Participate in study team, disease-site group and ongoing protocol training/ compliance meetings. If needed, collect, review and report timely, valid, accurate… more
- Charles River Laboratories (Horsham, PA)
- …and perform routine maintenance as needed. ⦁ Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...development of 86% of the drugs approved by the FDA in 2021. At Charles River Laboratories, we recognize… more
- GE HealthCare (State College, PA)
- …using precision measuring instruments (micrometers, calipers, CMMs). + Maintain documentation in compliance with FDA , ISO 13485, and GMP standards. + Collaborate ... with quality assurance and engineering teams to ensure product conformity. + Maintain a clean and organized work area, adhering to cleanroom protocols when required.… more
- UPMC (Bridgeville, PA)
- …in timely, safe and accountable manner. + Promote UPMC culture by providing quality , comprehensive services to all customers through a team approach. + Complete ... and/or equipment according to policy. + Maintain accurate and complete records in compliance with State, local, and Federal laws and/or regulations (including FDA… more
- UPMC (Bridgeville, PA)
- …in timely, safe and accountable manner. + Promote UPMC culture by providing quality , comprehensive services to all customers through a team approach. + Complete ... and/or equipment according to policy. + Maintain accurate and complete records in compliance with State, local, and Federal laws and/or regulations (including FDA… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... Reports (PMSR)** and **Periodic Safety Update Reports (PSUR)** in compliance with global regulatory standards. + Drive **risk analyses**...or complaint handling systems. + Understanding of ISO 13485, FDA 21 CFR Part 820, or EU MDR regulations.… more
- Fujifilm (Harrisburg, PA)
- …of the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Eliassen Group (Harrisburg, PA)
- …strengthen development efficiency * You'll interface with software test to ensure high quality product * You will develop automated unit and integration tests * ... applicable. BIG PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation. There will… more
- Penn Medicine (Philadelphia, PA)
- …and physicians in maintaining a patient/customer focus, supports the delivery of high quality care, shares a passion for patient and customer centered care, and ... process reports as requested. Other / Regulatory: + Ensures compliance with all applicable federal, state, and local regulatory...federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) + Flexible… more
- Penn Medicine (Philadelphia, PA)
- …practice/department by maintaining a patient-centered focus, assisting in the delivery of high- quality care, and helping to meet or exceed patient satisfaction and ... process reports as requested. Other / Regulatory: + Ensure compliance with all applicable federal, state, and local regulatory...federal, state, and local regulatory standards (eg, TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME). + Be flexible… more