Staff Engineer, Quality Systems: Compliance & CAPA Leader

JenaValve Technology, Inc.; Irvine (CA); Sur place; USD 140 000 - 170 000; Plein temps

Résumé du poste

JenaValve Technology, Inc. in Irvine, CA is seeking a Staff Engineer, Quality Systems to lead quality system activities across product development and commercialization.

The role ensures compliance with FDA 21 CFR 820, ISO 13485, EU MDR and MDSAP, and collaborates with Regulatory, Manufacturing Operations and R&D to drive CAPA, non-conformance, change control, audits and quality metrics. It also provides guidance on software validation and risk management.

Description du poste

JenaValve Technology, Inc. in Irvine, CA is seeking a Staff Engineer, Quality Systems to lead quality system activities across product development and commercialization.

The role ensures compliance with FDA 21 CFR 820, ISO 13485, EU MDR and MDSAP, and collaborates with Regulatory, Manufacturing Operations and R&D to drive CAPA, non-conformance, change control, audits and quality metrics. It also provides guidance on software validation and risk management.