- United Therapeutics (Silver Spring, MD)
- …automation, orchestration, and scale + Knowledge of specific pharmaceutical and medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Bausch + Lomb (St. Louis, MO)
- … quality and manufacturability of the PCB and cable designs, regulatory compliance and high- quality execution across multiple programs. The ideal candidate ... leadership, along with a thorough understanding of IEC 60601 standards, FDA and EU design control regulations, and risk management practices. **Responsibilities:**… more
- System One (Princeton, NJ)
- …maintain documentation in support of the Quality Management System (QMS), ensuring compliance with GMP and FDA standards. This role covers production and QC ... India and a growing presence in the United States. They provide high- quality biologics manufacturing services to global pharmaceutical clients. Position Overview The… more
- Actalent (Hadley, MA)
- …troubleshoot formulation or process-related issues. + Support regulatory submissions and ensure compliance with FDA , USDA, and other relevant standards. + ... you'll play a key role in ensuring the safety, quality , and consistency of our food ingredients and products....and Production to support product development and ensure regulatory compliance . Job Details: + Perform routine and non-routine chemical… more
- J&J Family of Companies (Athens, GA)
- …of standard processes. + Own process improvements related to safety, environmental, quality , compliance , productivity, yield, and cost. + Lead multi-functional ... processes, process validation, and continuous improvement methodologies + Knowledge of regulatory compliance standards ( FDA , EMEA, DEA) and audit readiness +… more
- J&J Family of Companies (Irvine, CA)
- …Non-Product Software (NPS) Validation while providing the guidance needed to ensure compliance with the company's Quality System policies, procedures and ... MedTech and software business (any combination of ISO 13485, FDA CSA, GAMP5, and Part 11 - or similar...on work experience in Digital Asset Management as Software Quality Engineer in terms of Compliance Assessment… more
- Rise Baking Company (York, PA)
- …required PPEs + Create, update, and audit sanitation program and all SSOPs to ensure compliance with FDA and GFSI requirements + Assist with updating quality ... Role) Job Purpose Lead the Sanitation team to achieve full plant compliance with sanitation/cleaning standards, food safety, and personnel safety, maintaining all… more
- Kentucky Blood Center (Lexington, KY)
- …issued by regulatory agencies and accrediting organizations to ensure KBC is in compliance with applicable AABB, FDA , CLIA, State, OSHA, and Short-Supply ... include computer software, as needed. + Oversees the implementation, auditing, and compliance with Quality System Essentials in assigned departments. +… more
- GE HealthCare (Waukesha, WI)
- …role is critical in ensuring that products are manufactured efficiently, safely, and in compliance with FDA , ISO, and GMP standards. The ideal candidate will ... + Develop, implement, and optimize manufacturing processes for medical devices, ensuring compliance with regulatory and quality standards. + Support new product… more
- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more