Staff Engineer, Quality Systems – MedTech Innovation

JenaValve Technology, Inc.; Irvine (CA); Sur place; USD 120 000 - 180 000; 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, ensuring compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and MDSAP.

You will collaborate with Regulatory, Manufacturing Operations and R&D to drive CAPA, non-conformance, change control, audits, and quality metrics, and provide guidance on software validation and risk management.

Qualifications

• Bachelor's degree in Biomedical Engineering or related field; MS preferred.
• 5+ years in medical device or pharmaceutical quality environment.
• Experience with FDA 21 CFR Part 820 and ISO 13485; regulatory awareness.

Responsabilités

• Collaborate with Regulatory, Manufacturing Ops and R&D to support QMS and core processes.
• Lead CAPAs, NCRs, MRB, internal audits and management reviews; drive improvements.
• Support FDA inspections, Notified Body audits, and supplier audits; close findings.
• Support software validation activities and related documentation and testing.
• Lead harmonization of quality KPIs across sites worldwide.
• Provide guidance on risk management and quality metrics trending.

Connaissances

Quality Engineering

Regulatory knowledge

Cross-functional collaboration

Project management

Communication

Risk management

Analytical thinking

Formation

B.S. Biomedical Engineering

M.S. preferred

Outils

eQMS

CAPA software

Audit tools

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, ensuring compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and MDSAP.

You will collaborate with Regulatory, Manufacturing Operations and R&D to drive CAPA, non-conformance, change control, audits, and quality metrics, and provide guidance on software validation and risk management.