- BD (Becton, Dickinson and Company) (San Diego, CA)
- …team, which is responsible for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the ... FDA and other regulatory agencies (eg, recall...as applicable. + Collaborates with leadership in Business Unit Quality , Regulatory Affairs, R&D, Operations, Service, Medical… more
- J&J Family of Companies (Santa Clara, CA)
- …track record of leading and facilitating successful audits and inspections with regulatory bodies including FDA and various Foreign Government Health Authorities ... including but not limited to R&D, Operations, Commercial, Supply Chain, Regulatory Affairs, Medtech/Enterprise, to assure quality and business deliverables… more
- Hologic (San Diego, CA)
- …document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements ( FDA , ISO, EU MDR). + Conduct initial assessments ... Quality Assurance Specialist (Post-Market) San Diego, CA, United...Regulatory Reporting + Support preparation and submission of regulatory reports (eg, FDA MDR, EU Vigilance,… more
- Abbott (Pleasanton, CA)
- …trends from various sources and proactively address regulatory , compliance, and quality issues. + Actively participate in FDA inspections and lead ... quality system requirements and how they impact product quality and regulatory compliance. + Represents the...environment. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies,… more
- Abbott (Temecula, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... and vendors. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- CSL Plasma (Fairfield, CA)
- …Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with ... This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and… more
- Kelly Services (Sacramento, CA)
- …ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , EMA, MHRA). The QA Manager will lead ... Review and approve change controls for appropriateness, completeness and alignment with quality , validation, and regulatory expectations. + Review and approve… more
- Hologic (San Diego, CA)
- …the company's quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. ... ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA...(EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards. + Extensive experience… more
- Abbott (Alameda, CA)
- …conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Element Materials Technology (Santa Fe Springs, CA)
- …such as deviations, Out of Specifications, and CAPAs, and preparation for client and regulatory audits. The ** Quality Supervisor n** ot only ensures that the lab ... **Overview** Element has a current opening for a ** Quality Supervisor** to join our growing team in...that the laboratory's output meets the highest scientific and regulatory standards. The role requires a deep understanding of… more