- Actalent (Hartland, WI)
- …inspections and batch record information, and ensuring compliance with GMPs, SOPs, FDA regulations, and quality processes. Responsibilities + Perform quality ... record information. + Ensure production personnel follow GMPs, SOPs, FDA regulations, and quality processes. Essential Skills + Quality control experience.… 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
- Stryker (San Jose, CA)
- … quality . + Lead service audits (internal and external, including Corporate and ISO/ FDA ) and monitor key quality metrics to drive continuous improvements. + ... + Knowledge of applicable domestic and international regulations and quality system standards - FDA QSR, MDD, ISO3485, ISO9001, etc. $130,700.00 - $173,000.00 -… more
- Abbott (Plymouth, MN)
- …studies, validations, calibration, test methods, and NCMR dispositioning. + Knowledge of Quality Systems, FDA regulations, ISO 13485, GMP, and applicable ... lives. We are seeking an experienced, high caliber Senior Technician for Supplier Quality to assist engineers in developing and maintaining quality engineering… 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
- Actalent (Fort Worth, TX)
- …consistent implementation of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and equipment validation ... Job Title: Quality /Regulatory Manager Job Description The Head of ...recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies, and Health Canada. + Develop, implement,… 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
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