- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …of Blood Banks (AABB) and the Food and Drug Administration ( FDA ). The Anatomic Pathology Division accessions approximately 10,000 surgical pathology specimens, ... lab, Cytopathology, Dermatopathology, and Hematopathology. The Service also provides Quality Management, Informatics and Telepathology support for the entire VISN1… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of… more
- Charles River Laboratories (Worcester, MA)
- …the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- J&J Family of Companies (Danvers, MA)
- …including test protocols, reports, and engineering rationales to support both quality and regulatory documentation. + Develop Test Methods and understand ... of Medical Device Design Controls and Product Life cycle + Knowledge of FDA and EU MDR regulations + Ability to communicate ideas and information clearly,… more
- Capgemini (Burlington, MA)
- …and mentor a team of verification engineers, promoting a culture of quality , collaboration, and continuous improvement. . Test Development: Design and implement both ... with relevant medical device regulations such as ISO 13485, IEC 62304, and FDA guidelines. . Defect Management: Lead root cause analysis and resolution of defects,… more
- Norstella (Boston, MA)
- …data and align insights with client needs. + Monitor and troubleshoot data quality issues, ensuring the integrity and reliability of insights provided to clients ... while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + Support client engagements by participating in scoping discussions and helping… more
- Fortrex (Woburn, MA)
- …safe and sanitary environment, apply now to contribute to our mission of delivering top- quality products. **WHO WE ARE:** + Leader in food safety solutions for both ... 450 plantas que limpia diariamente en norte America. Nosotros abarcamos USDA, FDA e instalaciones procesadoras de comida CFIA. Nuestros clientes trabajan fuertemente… more
- AbbVie (Worcester, MA)
- …renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA /GMP regulated environment. The engineer will work in a multi-disciplinary team ... as required + Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs Qualifications Key Stakeholders Engineering… more
- Chiesi (Boston, MA)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA , EMA, and other health authorities). + Leverage AI and data analytics… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... adapt to rapidly evolving situations and needs + Strong commitment to delivering high- quality work and upholding HCUS values. + Proficiency in Microsoft Word, Excel,… more