- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …for investigation and Regulatory Affairs for arranging more information/ samples from FDA . + Managing Quality Management Review meetings, circulating minutes of ... Quality Compliance Manager Department: Quality Location:...Product Recalls, making sure no delay in submission to FDA per defined timeline. After initial submission, keeping track… more
- Rise Baking Company (York, PA)
- …analysis and project management tools + Strong written and verbal communication skills + Strong knowledge of product quality , FDA , OSHA and EPA regulations ... continuous improvement and fact-based decision making + Support food safety program, quality standards, and legality of manufactured products + Comply with all food… more
- BioLife Plasma Services (Camp Hill, PA)
- …+ Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA -regulated environment. + Effective communication, ... performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is… more
- Philips (New Kensington, PA)
- …fit if:** + You have a minimum of 7+ years' experience in Post Market Quality within FDA regulated medical device environments, with a focus on Complaint ... evaluating, investigating, and resolving complaints and upholding high standards of service quality and customer satisfaction. **Your role:** + Manages a team of… more
- Lilly (Philadelphia, PA)
- …years' experience in lab management + Demonstrated advanced understanding of cGMPs, ICH Quality guidance, FDA CMC guidance + Demonstrated ability to communicate ... with unmet needs. **Position Overview:** The Director, Analytical Development and Quality Control (AD/QC) is responsible for managing the development and validation… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …capture improvement opportunities including non-product softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO ... (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
- Eliassen Group (Harrisburg, PA)
- …develop corrective actions + Ensure all written materials align with company, quality , and FDA guidelines across all manufacturing components **Experience ... Requirements:** + Ability to manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …understanding and working knowledge of appropriate global regulations and standards including FDA Quality System Regulations and ISO 13485:2016 + Strength in ... close with other functions both within and outside of Quality , including Regulatory Affairs, Information Technology, Service, Repair, Manufacturing, Commercial… more
- Teleflex (Wayne, PA)
- …internal resources. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... 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… more
- PCI Pharma Services (Philadelphia, PA)
- …years related experience in a regulated environment + Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical ... our global network to pioneer and shape the future of PCI. The ** Quality Systems Manager** is responsible for overseeing and maintaining the Electronic Quality… more