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Job #02918

About our client Our client is a leading healthcare company based in Redondo Beach that specializes in clinical diagnostics. They develop and manufacture clinical lab quality control products. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Quality Assurance/Regulatory Affairs Manager Redondo Beach, South California Salary Highly competitive package, commensurate with experience Responsibilities 1) Represent management for ISO and FDA 2) Define, administer and review the quality program 3) Resolve all conflicts between the quality program and any other policies, procedures or operation within the company as well as implement the necessary changes 4) Develop and effectively implement quality system procedures to ensure maintenance of GMP Class II Device Compliance, ISO 9001, ISO 13485 and CE Mark Certifications 5) Review and approve technical dossiers for submission to governing bodies 6) Manage internal and vendor audits according to FDA CFR 820, ISO 13485:2003 and European regulations 7) Obtain and renew licenses with US, Canada and international agencies 8) Manage document control activities (CR, NCMR and CAPA) 9) Perform other tasks and duties as directed by management and supervisory personnel 10) Assist in maintaining the company’s quality system 11) Supervise QA/RA staff 12) Maintain organizational relationships between departments Requirements 1) BS/MS in Life Sciences 2) QA/RA experience for IVDD and MDD 3) Experience in managing internal and vendor audits according to FDA CFR 820, ISO 13485:2003 and European regulations 4) Knowledge of ISO, FDA, GMP Class II device and CE Mark requirements 5) Knowledge of national and international license requirements