- Bayer (Berkeley, CA)
- …with transparency, fairness, and respect. + Comfortable utilizing a variety of computer systems and applications, demonstrating the ability to streamline and ... and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation , and Quality Systems (Deviation and CAPA management, Change… more
- Abbott (Temecula, CA)
- …design change projects + Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation ... + Lead design test and inspection method development, and lead method validation activities + Ensure DHF content completion, integrity, and regulatory & standards… more
- J&J Family of Companies (Santa Clara, CA)
- …organizational, problem solving, and analytical skills + Working knowledge of IEC 62304, FDA 's General Principles of Software validation , ISO 13485, ISO 14971, ... software architecture and design, product security, software verification and validation ) to ensure that they comply with applicable procedures standards… more
- Medtronic (Carlsbad, CA)
- …instruments, and systems , conducting product and use testing, and managing system interfaces. You will actively seek Voice of the Customer (VOC) input and ... evaluations, including numerical verification + Defines and performs verification and validation activities, ensuring products meet user needs, system … more
- Abbott (Sylmar, CA)
- …and responsibilities of the position. + Engineering experience (preferred) + Knowledge of FDA Quality System Requirements and other applicable US Code of Federal ... conform to quality standards and establishes compliance with the quality system . Responsible for maintaining a strong collaborative partnership with cross-functional… more
- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more
- Abbott (Alameda, CA)
- …**What you'll work on** + Lead software development, verification, and validation ; responsible for on-time delivery of high-quality embedded software biowearable ... approved design control procedures for software development in accordance with FDA guidelines. + Lead software development projects, providing mentoring and… more
- Actalent (Irvine, CA)
- Job Title: Quality Management Systems SpecialistJob Description We are seeking a Quality Management Systems Specialist who will be responsible for ensuring ... regulatory requirements, including but not limited to Site, Division, Corporate, FDA , ISO, MDD, and individual country requirements. This role involves engaging… more
- Bio-Techne (San Marcos, CA)
- …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
- Amgen (South San Francisco, CA)
- …or vivarium. + **Regulatory knowledge:** Experience handling GxP data and system validation . Knowledge of regulatory requirements affecting laboratory data ... degree OR Bachelor's degree and 2 years of Life Sciences, Bioinformatics, Computer Science, Information Systems , or related field experience Or Associate's… more