- Family Dollar (Chesapeake, VA)
- …industries. (pharmaceutical or medical device industry preferred). + Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR ... **Family Dollar** ** Quality Assurance Associate** _About Us_ Based in Chesapeake,...will assist in completing the day-to-day responsibilities of the Quality Assurance Manager for product quality , safety,… more
- Family Dollar (Chesapeake, VA)
- …industries (pharmaceutical or medical device industry preferred). . Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR ... will assist in completing the day-to-day responsibilities of the Quality Systems Manager for product quality , safety,...of the Quality Systems Manager for product quality , safety, efficacy, development, and compliance to cGMP requirements.… more
- Abbott (Sylmar, CA)
- …typical to meet the skills and responsibilities of the position. + Knowledge of FDA Quality System Requirements and other applicable US Code of Federal ... arrhythmias, or irregular heartbeats. We are seeking a high caliber **Software Quality Engineer I.** This position is responsible for executing and maintaining … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …them in a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface ... 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR's (21 CFR Part… more
- 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
- Hologic (San Diego, CA)
- …the company's quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. ... environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE… more
- Hologic (San Diego, CA)
- …cause analysis, and scientific problem-solving. + Experience with complaint investigation, CAPA, and quality systems ( FDA , ISO 13485, EU MDR). + Understanding of ... Scientist 3 - Quality Technical Investigations San Diego, CA, United States...a highly motivated Scientist 3 in our Diagnostic division, Quality Technical Investigations Team (QTI). In this role and… more
- Abbott (Santa Clara, CA)
- …with all levels of employees, customers, contractors, and vendors. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulator ... Our business purpose is to restore health and improve quality of life through the design and provision of...Heart Division of Abbott, reporting to the Manager of Quality . + Conduct functional testing as required by component… more
- Abbott (Santa Clara, CA)
- …with all levels of employees, customers, contractors, and vendors. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory ... Our business purpose is to restore health and improve quality of life by designing and providing device and...+ Recommend improvements to the production process to ensure quality control. + Responsible for completing documentation in a… more
- Danaher Corporation (Bothell, WA)
- …products, supporting facilities and equipment qualification, and strengthening compliance to FDA 's Quality System Regulation and ISO13485 Standard. This position ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Quality Assurance Engineer II is responsible for ensuring product… more