- Zimmer Biomet (Englewood, CO)
- …compliance. * Assisting project teams on compliance with design control requirements per FDA QSR, European MDR, ISO 13485 and other applicable ISO/EN standards. * ... Accurately represents quality processes to 3rd party auditors ( FDA , ISO 13485, MDSAP, etc.). * Other duties as assigned. **Your Background** **Qualifications** *… more
- BeOne Medicines (Pennington, NJ)
- …intermediates and finished biological products (monoclonal antibodies) under FDA /EU regulations, applicable International Regulations, and BeOne Medicines' processes ... preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.… more
- Edwards Lifesciences (Irvine, CA)
- …Experience working in complex, matrixed and global business environment + Experience with FDA guidelines for Software Quality and Systems Validation required + ... by Leadership **What you'll need:** + Bachelor's degree in computer science or related field + 4 years of...in complex global business environment + Prefer experience with FDA guidelines for Software Quality and Systems Validation… more
- BioBridge Global (San Antonio, TX)
- …develop testing procedures according to organizational and regulatory (NMDP, AABB, FACT, ISO, FDA , and cGMP) standards. Assist with validation of all procedures ... advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on… more
- Koniag Government Services (Silver Spring, MD)
- …regulatory applications and scientific reports, ensuring accuracy and completeness + Utilize FDA -provided Oracle or Access databases, or other computer systems, ... for data input as required + Perform data validation and quality control functions to maintain data integrity...+ Proficiency in using databases (eg, Oracle, Access) and computer systems for data input and management + Strong… more
- Cardinal Health (Salem, OR)
- …of a dataset's origin, transformations, and access for regulatory reporting. + Support the validation of computer systems used for GxP data to ensure they comply ... with regulations set by agencies such as the US Food and Drug Administration ( FDA ) and the European Union under the EU 2017/745 Medical Device Regulation (EU MDR)… more
- Integra LifeSciences (Princeton, NJ)
- …(ISO 13485) standards is required + Knowledge of 21 CFR Part 11 and Computer /Quality System Software validation is required + Strong oral and written ... in compliance with US and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International… more
- ABM Industries (Carlsbad, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Understands and is aware of the ... in their area of responsibility, including product design, verification and validation , manufacturing and testing activities. + Serve as system administrator,… more
- Katecho (Des Moines, IA)
- …operations, personnel management, and adherence to and administration of ISO 13485 and FDA , Title 21 Part 820, QSR. + Work with other departments to determine ... as required. + Assist in quality audits including, but not limited to, FDA , Customer Audits, Supplier Audits, and Internal Audits. + Serve as Quality technical… more
- Epredia (Portsmouth, NH)
- …marketing, R&D organizations, customers and other plants. + Design and execute Validation and/or Qualification exercises in accordance with FDA General ... What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and...clients to carry out the work assigned. + Advanced computer skills, Windows Suite, CAD, Label design. + Advanced… more