- ARTIDIS (Houston, TX)
- …or diagnostics environment + Sound knowledge of ISO 13485:2016 and an understanding of FDA Quality System Regulation (21 CFR Part 820) + Hands-on experience in ... driving efficiency, and ensuring that our transformative technology consistently meets FDA requirements and internal quality benchmarks, ultimately supporting… more
- Houston Methodist (Houston, TX)
- …and off site. + May assist in the preparation of periodic reports for FDA . ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Provide routine updates and reporting to the ... Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on… more
- Houston Methodist (Houston, TX)
- …service focus and application of positive language principles + Familiar with quality , compliance and FDA regulatory requirements for Good Laboratory Practice ... will be responsible for all aspects of compliance associated with the quality operations including, but not limited to, review of procedures, verification of… more
- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, USA) ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product-Regulatory-Manager\_R2060938/apply) Return to Job Finder At Dow, we believe… more
- Eliassen Group (Austin, TX)
- …develop corrective actions + Ensure all written materials align with company, quality , and FDA guidelines across all manufacturing components **Experience ... Requirements:** + Ability to manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset… more
- Abbott (Austin, TX)
- …to meet the skills and responsibilities of the position. + Substantial knowledge of FDA and ISO Quality System Requirements and other applicable US Code of ... Our 114,000 colleagues serve people in more than 160 countries. **Director- Site Quality Head** **The Opportunity** Abbott Diabetes Care has an opportunity for a… more
- ZOLL Medical Corporation (Austin, TX)
- …Utilize organizational process control systems and industry privacy requirements (ie, FDA quality controls, HIPAA) Required/Preferred Education and Experience + ... the value of strong development best practices and automated testing to protect quality . They actively participate in the product's development by engaging with the… more
- BioBridge Global (San Antonio, TX)
- …and/or verifications from start to finish. **Knowledge** Must maintain familiarity of regulatory/ quality compliance, to include FDA , EU, ISO, GHM, cGMP, OSHA, ... with the development of project plans and budgets. Establish operating parameters and quality control limits as required. Assisting with the resolution of quality… more
- Veterans Affairs, Veterans Health Administration (Temple, TX)
- …functions and Quality Assurance Knowledgeable of Food and Drug Administration ( FDA ) and Mammography Quality Standards Act (MQSA) Regulations and Requirements ... compliance with all QC and QA requirements as per VHA policy, FDA /MQSA regulations, and ACR standards in mammography, digital breast tomosynthesis, breast… more
- UTMB Health (Galveston, TX)
- …funding agencies to design and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize the US ... Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point… more