- Sanofi Group (Framingham, MA)
- …Global Quality . . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA inspection findings and best ... Advocacy Leadership Team + **Lead cGMP compliance projects** aligned with the company's Quality Operations strategy and US FDA regulations. + **Drive digital… more
- 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
- United Therapeutics (Christiansburg, VA)
- …in the management of complex staff and organizational issues + Experience managing FDA inspections + Applied knowledge of GxPs/ Quality Systems, USDA/ FDA ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Abbott (Plymouth, MN)
- …Gage R&R, calibration, test methods, and NCMR dispositioning. * Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory ... position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within… more
- Abbott (Sylmar, CA)
- …Gage R&R, calibration, test methods, and NCMR dispositioning. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory ... position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within… 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
- Caldera Medical (Westlake Village, CA)
- …Provides a key role in assuring organizational compliance with the defined Caldera Medical quality system, FDA QSR/GMP regulations, ISO 13485 quality system ... Quality Engineer - Westlake Village, 100% ONSITE Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: The … 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,...international regulations and quality system standards - FDA QSR, MDD, ISO3485, ISO9001, etc. Health benefits include:… more
- Abbott (Alameda, CA)
- …+ Ensures internal activities and external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485 + ... Ensures external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485. + Assists in the evaluation,… more
- Catalent Pharma Solutions (Harmans, MD)
- …and establishing validation policies and strategies that align with Catalent's quality standards, FDA /EMA requirements, and industry best practices. This ... of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
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