- PCI Pharma Services (Rockford, IL)
- …candidate will lead equipment, process, and cleaning validation efforts to ensure compliance with FDA , ISO 13485, and other applicable regulatory standards. ... Validation Engineer - Medical Device Assembly (CDMO)** **Location:** [Rockford] **Department:** Quality **Reports To:** Director of Quality **Position Summary:**… more
- State of Colorado (Denver, CO)
- …and electrical troubleshooting skills + Working knowledge of medical equipment regulatory compliance (eg, The Joint Commission, FDA , NFPA, CDPHE, manufacturer ... serving our community. The vision of CMHH-FL is to provide the highest quality mental health services to persons with complex, serious, and persistent mental illness… more
- Unither Pharmaceuticals (Rochester, NY)
- …executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance as well as system and user acceptance testing is consistently met along with ... and Capsules. It has more than 280 employees. Your role Reporting to the Quality Director, JOB SUMMARY: This is a team-oriented position with the individual actively… more
- University of Pennsylvania (Philadelphia, PA)
- … meetings. Demonstrate vigilance in patient safety, protocol compliance , and data quality . Adhere to all University of Pennsylvania, FDA and GCP guidelines. ... participate in study team meetings, and follow all University of Pennsylvania, FDA , and GCP guidelines. Participation in study initiation, monitoring, audit, and… more
- University of Maryland, Baltimore (Baltimore, MD)
- …performance and quality control tests. . Increased effort to ensure technical compliance with changing Joint Commission and ACR quality control and image ... with the radiation safety office with respect to regulatory compliance . This position will also participate in all facets...investigators so that their reports are in alignment with FDA annual reporting requirements. . Manage all interactions with… more
- J&J Family of Companies (Santa Clara, CA)
- …systems being developed + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned ... related to company's products + Interface with R&D, Regulatory, Quality , IT and other cross-functional stakeholders to ensure acoustic...the area of algorithm and acoustic tools development (in compliance with IEC and FDA standards) +… more
- Avera (Sioux Falls, SD)
- …Assists with the analysis, collection, and maintenance of records as needed by Quality Assurance, FDA , CAP, Joint Commission accreditation, OSHA guidelines, or ... Brief Overview** Specializes in collecting blood from donors in accordance with FDA guidelines, using both traditional as well as apheresis procedures, and assumes… more
- Alaka'ina Foundation Family of Companies (Frederick, MD)
- …business days of completion and approve data for release to ensure correctness and compliance with quality control and quality assurance guidance. + ... diagnostic assays from research use to assay production or FDA pre-EUA approval; to include but not limited to,... Animal Rule, CLIP, COLA). + Procure key reagents, quality control materials; ensure integrity of reagent and … more
- Ochsner Health (New Orleans, LA)
- …determines donor suitability and collects blood from prospective donors. Performs quality control, operates the computer, and completes other administrative and ... health history confidential interview according to SOP, AABB Standards and FDA Regulations. Perform volunteer, autologous, directed donor and therapeutic phlebotomy… more
- Stanford University (Stanford, CA)
- …multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance , and fiscal ... for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to… more