Project Validation Specialist Eu Mdr

We are seeking a highly experienced EU MDR Compliance Specialist to join our team at Labchems Corp. As a critical member of our compliance team, you will be responsible for ensuring that our company remains compliant with EU MDR regulations. Your expertise in validation activities, project management, and technical documentation will be essential in...

Company OverviewLabchems Corp. is a leading manufacturer of high-quality laboratory chemicals and equipment. Our commitment to innovation and customer satisfaction has earned us a reputation as a trusted partner in the scientific community.Job DescriptionWe are seeking a highly skilled EU MDR Compliance Specialist III to join our team. The successful...

Labchems Corp. seeks a highly skilled Validation Specialist to join our team in supporting the EU MDR program. As a key member of our team, you will be responsible for ensuring compliance with EU MDR regulations by conducting thorough gap assessments and developing comprehensive remediation plans. Your expertise in validation activities, project management,...

Support the European Union Medical Device Regulation (EU MDR) program with the following activities: Data Gathering–Participate in the discovery and compilation of required documentation to be evaluated. Gap Assessments–Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production...

Job OverviewLabchems Corp. is seeking a highly skilled Medical Device Validation Engineer to support the European Union Medical Device Regulation (EU MDR) program.About the RoleThe successful candidate will participate in data gathering, gap assessments, remediation planning, and documentation generation and execution for EU MDR compliance.Key...

The position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.• Data Gathering – Participate in the discovery and compilation...

Job RequirementsWe are seeking an experienced Quality Assurance and Validation Lead to join our team. The successful candidate will be responsible for ensuring the quality and integrity of our products and processes.About the RoleThe Quality Assurance and Validation Lead will be responsible for:Supporting the development and implementation of quality and...

The role of this position is to provide support to the European Union Medical Device Regulation (EU MDR) program at Labchems Corp. The successful candidate will be responsible for participating in data gathering and compilation of required documentation, conducting gap assessments on manufacturing documentation, and performing remediation tasks.Key...

At Labchems Corp., we are seeking a Senior Validation Specialist to support the efficient completion of project-related tasks for the sterilization area. This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements.The ideal candidate will have advanced...

Support CORPORATE STERILIZATION WORKSTREAM for efficient and timely completion of project related to sterilization area including, new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements, among others. Interprets microbiological testing data, monitors, and maintains...

We are a Service Provider company different from the rest. Flexible & Integrated Technical Services, Llc prides ourselves in how we treat the most important piece of our company's puzzle: you**Job Summary:**This role will be responsible for ensuring timely and thorough execution of Computer System Validation protocols, meeting FDA requirements. You will...

We are seeking a Validation and Sterilization Professional to support our corporate sterilization workstream. As a senior-level professional, you will be responsible for supporting the efficient completion of project-related tasks for the sterilization area.This includes new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization...

Sobre Nosotros">Somos Spectraforce, un líder en la industria de los productos médicos. Nuestro equipo trabaja incansablemente para asegurar que nuestros productos cumplan con las normas más altas de calidad y seguridad.">Descripción Del Puesto">Nuestra búsqueda es para un Especialista En Calidad que se una a nuestro equipo de ingeniería de producto en...

Job DescriptionWrite, execute and maintain validation protocols on a timely basis.Ensure thorough and complete execution of all protocols, meeting FDA requirements.Develop documentation of investigations and communicate findings to minimize chance of recurrence.This role requires strong technical skills in SOP development, validation documentation, GMP and...

As a Validation & Quality Engineer at Flexible & Integrated Technical Services, LLC, you will be an integral part of our team, contributing to the success of our clients in the Pharmaceutical, Medical Device, and Manufacturing industries. Key responsibilities include:Developing SOPs and ensuring compliance with regulatory guidelinesSupporting the execution...

**Job Summary:**Labchems Corp. seeks a highly skilled Quality Assurance Specialist to support our facilities and construction projects in Collagen areas.The ideal candidate will be part of the Core Team, participating in meetings and reviewing/approving all documentation required for project success.This role involves developing technical documentation,...

•Trabajar en la documentación de pFMEA y Gestión de Riesgos para transferir a las últimas plantillas GSOP-504 y garantizar que la documentación cumpla con la norma ISO 14971.•Trabajar con los equipos de proyecto para calcular los valores de p1 en función de la documentación técnica e incluir la justificación para respaldar estadísticamente los...

Job Overview">At Labchems Corp., we are seeking a highly skilled Quality Assurance Specialist to support our facilities and construction projects. As a key member of the Core Team, you will participate in meetings and review/approve all documentation required for facility projects. Your primary responsibilities include developing technical documentation,...

Sobre Nosotros">Somos Spectraforce, una empresa comprometida con la innovación y la excelencia en la industria de los productos médicos.">Descripción Del Puesto">Buscamos a un Gerente De Procesos Normativos que liderará nuestros esfuerzos en la implementación y seguimiento de los procedimientos de calidad y seguridad.">Responsabilidades">">Desarrollar y...

Sobre Nosotros">Somos Spectraforce, una empresa líder en la industria de los productos médicos.">Descripción Del Puesto">Buscamos a un Ingeniero De Desarrollo Y Cumplimiento que se encargue de asegurar que nuestros productos cumplan con las normas más altas de calidad y seguridad.">Responsabilidades">">Diseñar y desarrollar soluciones técnicas que...