- Olympus Corporation of the Americas (Center Valley, PA)
- …assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports and… more
- United Therapeutics (Harrisburg, PA)
- …you're passionate about pharmacovigilance! You are a team player who loves quality , compliance , finding solutions and ensuring training standards are implemented ... This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality , training, and compliance (QTC) of GPS operations and practices. They… more
- Teleflex (Wayne, PA)
- …needs with available internal resources. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the ... 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
- 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)
- …members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations. **Education** + ... planet through our sustainability efforts. **Job Summary** The Principal, Quality Assurance, GMP role focuses on ensuring compliance...SME group. + Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as… more
- PCI Pharma Services (Philadelphia, PA)
- … Systems Manager** is responsible for overseeing and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory ... deviations, and complaints to identify patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and… more
- Charles River Laboratories (Wayne, PA)
- … Compliance management team. Provides direction in implementing the Charles River Compliance Program and may lead corporate quality initiatives to improve the ... program. **Essential Duties** ⦁ Communicate all identified compliance and quality risks to his/her supervisor....drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- ThermoFisher Scientific (Allentown, PA)
- …meet current regulatory expectations. **Key responsibilities:** Support the established Quality Compliance strategy. Work to ensure continuous improvements ... Director will engage with key global regulators to include FDA , EMA, and ANVISA; and identify mechanisms to assure...for inspection management for key inspections. Develop and maintain quality assurance and compliance polices and standard… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …Quality Systems Manager will collaborate with business users, IT teams, and quality collaborators to drive adoption, ensure compliance , and improve the ... used by Quality and Regulatory. + Analyze Quality and Compliance processes, translate Quality...including 21CFR820, 21CFR803, ISO 9001, ISO 13485, IVDR, cGMP's, FDA Guidelines, USP, and GxP. + Detailed knowledge of… more
- Envista Holdings Corporation (Quakertown, PA)
- …with Regulatory Affairs, Engineering, Operations, and Purchasing/Procurement to ensure product quality and compliance requirements are met with on-going ... + Execute process improvements as they relate to QMS compliance with ISO/GMP requirements + Identify and drive Corrective...fields required. + 1+ years of experience in progressive Quality Assurance role and exposure to FDA … more