- Hologic (Marlborough, MA)
- …apply and make an impact on healthcare innovation. **Knowledge:** + Expertise in FDA Quality Systems Regulation (QSR), Design Control requirements, ISO 13485, ... Quality Design Engineer II** to lead design changes, product enhancements, and quality projects while ensuring compliance with regulatory standards. In this… more
- UCHealth (Aurora, CO)
- …successful completion * Mandated Reporting * Identify and report safety occurrences per regulatory requirements (CDPHE, FDA ) * Review and respond to ... onsite role and does not offer a hybrid or remote option. UCHealth Clinical Quality and Safety Specialist (CQSS) - Safety * Safety Occurrence Management * Performs… more
- Sysco (Ankeny, IA)
- …safety regulatory requirements (Federal, State/Provincial and, Local) including US FDA Seafood HACCP, FSMA Preventive Controls for Human Foods, FSVP, 204 ... as the lead for product recall execution and internal communications, regulatory inspections completed by local, state/provincial, and/or federal regulatory … more
- Cardinal Health (Indianapolis, IN)
- …both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training ... for our customers and communities. **What a Senior Specialist, Quality Control (Chemistry) contributes to Cardinal Health** Quality...in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for… more
- PCI Pharma Services (Philadelphia, PA)
- …the site for inspection by regulatory authorities. + Participate in regulatory inspections as required. + Develop new Quality System procedures, and ... our global network to pioneer and shape the future of PCI. The Quality department is responsible for creating/maintaining the Quality Management System (QMS)… more
- University of Michigan (Ann Arbor, MI)
- …and Regulatory Readiness. This position will be part of the Quality Department. The Accreditation and Regulatory Readiness Director is responsible for ... Administration ( FDA ) Good Tissue, and other related accreditation and regulatory agencies. + Proactively designs, develops, evaluates, and implements the UMH-AMC… more
- University of Colorado (Aurora, CO)
- …and professional growth. + Develop and implement SOPs, training programs, and quality management systems for the IND/IDE office + Oversee preparation, submission, ... Collaborate with investigators, IRBs, research administration, and legal teams to navigate regulatory pathways for novel therapeutics and devices + Convene and lead… more
- Colgate-Palmolive (Tonganoxie, KS)
- …and regulatory compliance. + Identifies continuous improvement opportunities for Quality and Micro issues. + Conducts training for plant personnel regarding ... Together, let's build a brighter, healthier future for all. ** Quality Technician - Chemist (3rd Shift)** Are you ready...Able to quickly retrieve and understand data to support FDA , USDA, external and internal audit requests. + Works… more
- Hologic (Louisville, CO)
- …impact in the healthcare industry. **Knowledge:** + Strong understanding of Quality Management Systems (QMS) and regulatory requirements, including field ... systems. **Behaviors:** + Proactive and detail-oriented, ensuring timely execution of quality processes and compliance with regulatory requirements. +… more
- Danaher Corporation (Carlsbad, CA)
- …for consumables for SCIEX, and instrument company. This position is part of the Quality Assurance and Regulatory Affairs department and will be in Carlsbad. Our ... to deliver growth and innovative, reliable solutions for customers worldwide? The Senior Quality Engineer is a technical Quality subject matter expert that… more