- Guthrie (Sayre, PA)
- …direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 years of experience in managing a ... Operations & Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). + Experience in integrating clinical research into… more
- Philips (New Kensington, PA)
- …the right fit if:** + You have a minimum of 5+ years' experience within FDA regulated medical device Quality environments, with a focus on CAPA reviews, ... The Senior Quality Engineer-CAPA will play a critical role within...workflow. + You're able to understand/analyze complex problems, including software /hardware design issues and have demonstrated knowledge of the… more
- dsm-firmenich (Exton, PA)
- ** Quality Engineer II** **Exton, PA** **(Hybrid: On-Site 3 Days Per Week)** The ** Quality Engineer II** will support engineering activities for all product ... and deviations + Conduct statistical analysis and support key customer accounts as Quality Lead + Assist in the performance of qualification and validation studies +… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- Quality Assurance Associate - Inspection Department: Quality Location: Allentown, PA START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3450184&source=3450184-CJB-0) About the Job Carrying out Quality Inspection of all incoming batches including return goods… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- Quality Assurance Associate - Batch Release Department: Quality Location: Allentown, PA START YOUR APPLICATION ... the Job This position is responsible for batch disposition and other quality functions in the pharmaceutical distribution center. Job Responsibilities Note: These… 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
- 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 ... design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The… more
- Sumitomo Pharma (Harrisburg, PA)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... including computer word processing, electronic document management systems, and regulatory publishing software . + Robust understanding of FDA and other health… 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 ... and development of surgical instruments and implants using CAD software (CREO). + Create and maintain project plans and... (CREO). + Create and maintain project plans and FDA -compliant Design History Files (DHF) for each project. +… more
- Teleflex (Wyomissing, PA)
- …medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in ... the ongoing lifecycle management of vascular access devices, ensuring product quality , regulatory compliance, and manufacturing efficiency. This role focuses on… more