- Fujifilm (Raleigh, NC)
- …policies, and procedures. + Effective communication within FUJIFILM IVD organization of sales, quality and compliance issues. + Utilization of the IVD reporting ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... Maintain documentation for all automation solutions, ensuring clarity, traceability, and compliance with internal standards + Lead the end-to-end design and… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA … more
- CSL Plasma (Winston Salem, NC)
- …+ In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates vein ... to the Assistant Center Manager **The Role** + In compliance with SOPs perform all aspects of the pheresis...in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient… more
- Prime Therapeutics (Raleigh, NC)
- …improvement efforts based upon business needs. + Collaborates with Clinical Operations IT, Quality , and Compliance as needed for program support. + Other duties ... necessity criteria through evaluation of available clinical evidence (eg, FDA labeling, pivotal clinical trials, authoritative compendia, peer-reviewed literature).… more
- Papa John's International (Garner, NC)
- **Job Summary** The Production Team Member is responsible for producing high quality dough within PJ Food Service specifications, maintaining all equipment in a ... wearing the proper safety equipment/uniform. + Perform general housekeeping for the Quality Control Center as requested. + Operate floor maintenance equipment to… more
- Cole-Parmer (Raleigh, NC)
- …and troubleshooting abilities + Adherence to quality systems with special regard to FDA , ISO 13485 and GMP / OSHA compliance + QC testing of components ... as well as document generation and completion. Key Responsibilities: + Execution of quality system procedures + Proper execution of SOPs and work instructions for… more
- Fujifilm (Raleigh, NC)
- …consistently high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that ... with MI Project Management (PM) team to deliver high quality Synapse product solutions. + Act as primary technical...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- BioLife Plasma Services (Raleigh, NC)
- …your skills by contributing to financial, marketing, administrative, regulatory, quality , people, and facilities management. + **Contribute to Creating Life-Changing ... Medicines:** Maintaining our exceptional quality and service standards is key to creating life-changing...skills to meet production and cost goals while ensuring compliance with regulations and BioLife SOPs. + **Travel Opportunities:**… more
- Teleflex (Morrisville, NC)
- …* Document newly implemented or existing systems and processes according to quality , compliance , and regulatory requirements * Identify and address technical ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...across many disciplines + Working knowledge of SOX and FDA 21 CFR Part 820 requirements + Firm understanding… more