- Abbott (San Diego, CA)
- …Manufacturing Engineering teams to complete system/software requirements and other verification and validation tasks. + Ensure compliance to relevant FDA QSR, ... Abbott Corporate requirements as they relate to the development, validation and maintenance of product and non-product software. +...of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ISO 13485. + Advanced… 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
- Medtronic (Irvine, CA)
- …qualifications. Responsibilities of this position will include project management, validation procedures, manufacturing job instructions, execution of the ... best practices. Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to… 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
- Abbott (Pomona, CA)
- …etc. + Ensuring that the manufacturing area is compliant with all required FDA , ISO and other applicable regulatory agency standards and documentation + Responsible ... on-going training and guidance to staff + Responsible for the ongoing FDA /ISO compliant, cost-effective manufacture of specific products or sub-products + Review… more
- BeOne Medicines (Emeryville, CA)
- …as analytical/QC SME in the areas of method qualification/ validation /transfer, specification development and management, stability studies, shelf-life updates ... + Manage stability studies at CMOs + Manage methods transfer and methods validation activities to CMOs, including transfer/ validation strategy and approval of… more
- Abbott (Pleasanton, CA)
- …definition and management, design documentation, and system testing, verification, and validation . **What You'll Work On** + Lead product definition, system ... senior management. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Medtronic (Irvine, CA)
- …procedures. + Implements and validate methods and procedures for inspections and Validation testing. + performs statistical analysis to support quality decisions. + ... Criticality Analysis (DFMECA). + Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971 and Good Documentation Practices (GDP).… more
- Actalent (Irvine, CA)
- …the development process. + Support the definition of design verification and validation test requirements to ensure appropriate objective evidence is available to ... support the acceptance criteria. + Complete final design verification and validation reports with concise conclusions, statistical validity, and graphical support. +… more
- Abbott (Pleasanton, CA)
- …to work area. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and ... task assignments. **Required Qualifications** + Bachelor's Degree in Engineering ( Computer , Electrical, Software, or Biomedical), Computer Science, or related… more