- Stryker (Irvine, CA)
- …implement CAPAs for process-related issues. + Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO ... 25539 (vascular implants). **What you need:** Required Qualifications: + Bachelor's degree in Engineering (Mechanical or Biomedical preferred) + 2+ years of work experience Preferred Qualifications: + Experience in process development/manufacturing… more
- Avispa Technology (Santa Rosa, CA)
- …maintain calibration systems, procedures, and methods. * Promote ESD, service note compliance , and other programs that are conducive to the delivery of high-quality ... Institute (NMI). * Knowledge of current quality standards for ANSI/ ISO 9001, ANSI/Z540-3, and ISO 17025. *...quality standards for ANSI/ ISO 9001, ANSI/Z540-3, and ISO 17025. * Adapt to continuously changing technologies with… more
- Northrop Grumman (Redondo Beach, CA)
- …Understanding and experience with configuration management standards and practices (eg, ISO , ANSI, CMII). + Proficient in using configuration management software ... Understanding and experience with configuration management standards and practices (eg, ISO , ANSI, CMII). + Proficient in using configuration management software… more
- Noblis (San Diego, CA)
- …team. + Read and understand engineering drawings for quality inspections. + Maintain compliance with standards of the NIEF quality management system (QMS) for ISO ... quality events to the team lead. + Follow all applicable regulations, including ISO and company policies, procedures, and standards to provide the highest level of… more
- Northrop Grumman (Goleta, CA)
- …to existing processes to enhance product quality and performance + Ensure compliance with industry standards and regulatory requirements related to product quality + ... control, or a similar in a manufacturing environment + Experience with AS9100/ ISO 9001 Quality Management System (QMS) standards + Strong analytical and… more
- Abbott (Sylmar, CA)
- …software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the application of ... US Code of Federal Regulations for Devices Preferred. + Knowledge of ISO 13485 standard. Knowledge of quality management techniques and application. + Ability… more
- Parker Hannifin Corporation (Simi Valley, CA)
- …from supplier base and facilitates corrective actions as appropriate. + Ensures compliance to procedures and requirements outlined in the Supplier Quality Manual and ... analysis tools + Prefer at least two of the following certifications: ISO Lead Auditor Certification, ASQ Certification, Six Sigma Green/Black Belt Certification,… more
- Parker Hannifin Corporation (Simi Valley, CA)
- …to questions from Team Members, Suppliers and Customers + Create compliance matrices for customer specifications, quality requirements, and contractual documents + ... data analysis tools + Prefer at one of the following certifications: ISO Lead Auditor Certification, ASQ Certification, Six Sigma Green/Black Belt Certification,… more
- Turner & Townsend (San Francisco, CA)
- …upon ways to improve internal systems and processes. + Quality Control - Ensure compliance with quality standards and participation in ISO audits. + Develop ... facilities + Deep understanding of Good Manufacturing Practice (GMP), FDA, ISO , and other relevant standards. + Familiarity with cleanroom classifications, HVAC… more
- ThermoFisher Scientific (West Hills, CA)
- …performance objectives, training needs, and career development plans for the team. ** Compliance & Risk Management** + Ensure the team, process, and systems align ... with applicable regulations (FDA, 21 CFR Part 820, Part 11, ISO 13485, IVDR, ISO 17025). + Own or support equipment/software validation protocols and risk… more