Senior Quality Systems Engineer - Global Compliance & CAPA

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA is seeking a Principal Engineer, Quality Systems to own Quality Systems and Quality Engineering tasks for new product development and commercialization, ensuring compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and MDSAP.

You will lead lifecycle quality activities across CAPA, NCRs, change control, and quality metrics. You will collaborate with Regulatory, Manufacturing Operations, and R&D, drive QMS enhancements, support inspections, and guide software

Qualifications

• Bachelor of Science in Biomedical Engineering or equivalent required; MS preferred.
• 10+ years in medical device/pharma with Quality Systems/Quality Engineering experience.
• Expert knowledge of 21 CFR 820, ISO 13485, ISO 14971; audit and CAPA experience.
• Experience in regulated manufacturing and software validation for quality systems.

Responsibilities

• Collaborate with Regulatory, Manufacturing Operations, and R&D to support QMS and eQMS validation.
• Lead CAPA, NCRs, MRB, internal audits, management reviews, and quality metrics.
• Support FDA inspections, Notified Body audits, supplier audits, and audit findings closure.
• Drive digital transformation through modern analytic tools and automation for quality monitoring.
• Harmonize quality KPIs across all sites globally.
• Oversee software validation, including user requirements, risk assessments, testing, and reports.
• Support RGA process compliance and maintain traceability to complaints and QMS records.
• Provide SME guidance to quality specialists and junior engineers.
• Mentor teams and promote a proactive quality culture.

Skills

Quality Systems

Risk Management

Statistical Methods

Project Management

Cross-functional Collaboration

Regulatory Understanding

Communication Skills

Education

Bachelor of Science in Biomedical Engineering

Master of Science (MS) preferred

Tools

eQMS

Validation Documentation

Job description

JenaValve Technology, Inc. in Irvine, CA is seeking a Principal Engineer, Quality Systems to own Quality Systems and Quality Engineering tasks for new product development and commercialization, ensuring compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and MDSAP.

You will lead lifecycle quality activities across CAPA, NCRs, change control, and quality metrics. You will collaborate with Regulatory, Manufacturing Operations, and R&D, drive QMS enhancements, support inspections, and guide software