- Abbott (Alameda, CA)
- …and projects. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... tools/methodologies. + Prior medical device experience preferred. + Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:… more
- Merck (West Point, PA)
- …reduce unplanned downtime, and extend asset life while ensuring compliance with FDA , EMA, and other regulatory requirements. + Collaborate closely with Quality ... Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements ( FDA , EMA, GMP). + Expertise in reliability engineering tools and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …impact of regulatory guidelines from the US Food and Drug Administration ( FDA ), European Medicines Agency (EMA), or the International Council for Harmonization (ICH) ... and other stakeholders to understand research priorities. + Conduct background research on FDA , EMA, and ICH guidelines, or other relevant data to support Gilead's… more
- Medtronic (Northridge, CA)
- …document design verification test protocol, plans, and reports in compliance with FDA /ISO and global regulations. + Stay current with industry standards and ... Engineering. + Familiarity with lab/testing environment. + Experience in Medical Device/ FDA Regulated Industry and compliance with IEC60601-1-2. + Familiarity with… more
- Abbott (Alameda, CA)
- …practices. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... Qualifications** + Prior medical device experience preferred. + Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:… more
- Adecco US, Inc. (Alexandria, VA)
- …quality control programs in a food-production facility + Understanding of FDA /USDA regulations and food safety principles + Experience with cleaning/sanitation ... to multitask in a fast-paced environment + Prior experience with USDA, FDA , and GMP is preferred **Key Responsibilities** + Recommend and support improvements… more
- Actalent (Maple Grove, MN)
- …3 to 5 years in Quality. + Deep understanding of CE Marking, EU MDR, FDA Medical Device Regulation (MDR), and FDA requirements. + Extensive knowledge of ... manufacturing processes and practices relevant to the company's products. + Proficiency in Microsoft Office applications including Excel, Word, and Outlook. + Ability to work collaboratively across all organizational levels. + Strong leadership skills to… more
- Abbott (Sturgis, MI)
- …to detail + You'll be accountable for meeting our compliance standards including FDA , OSHA, SQF, along with any other applicable compliance standards as well as ... and procedures You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **Required Qualifications** + High… more
- Actalent (Fullerton, CA)
- …and personal care raw materials meet US and international regulations, including FDA , EU Cosmetics Regulation, REACH, and Prop 65. This role manages regulatory ... manufacturing + Experience in compliance with raw materials. + Knowledge of US FDA (CFR 21) regulations. Additional Skills & Qualifications + 2-3 years of experience… more
- System One (Morristown, NJ)
- …experience in the food, dietary supplement, or nutraceutical industry. + Knowledge of FDA food regulations, HACCP, and HARPC + Strong skills in managing technical ... interpret Certificates of Analysis (CoAs) and regulatory documents + Familiarity with FDA guidelines and industry standards for testing and compliance + Knowledge of… more