- Insight Global (Murrysville, PA)
- …SDLC to help drive streamlined solutions Perform code reviews with focus on quality , FDA standards, compatibility, and security. Analyze test results and share ... medical device clients. These testers will be responsible for ensuring the quality , privacy, compatibility, and reliability of all medical devices. This candidate… 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
- 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
- West Pharmaceutical Services (Exton, PA)
- …team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations. **Education** ... of the global SME group. + Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR… more
- Philips (Reedsville, PA)
- …and EU MDR Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate ... preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government agencies. Ensure regulatory submissions are… 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 (Wyomissing, PA)
- …in production. * Ensure projects are developed and documented in compliance with the Quality System and with FDA and ISO standards. * Comply with Teleflex's ... design control processes, regulatory requirements (eg, ISO 13485 and FDA 21 CFR 820) and quality standards...13485 and FDA 21 CFR 820) and quality standards for medical devices. * Understanding of design… 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