Lead Quality Systems Architect, Medical Devices

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

Job summary

Jenavalve Technology Inc in Irvine, CA seeks a Principal Engineer, Quality Systems to lead CAPA, NCRs, change control, audits, and QMS improvements for medical devices under FDA 21 CFR 820 and ISO 13485. You will collaborate across Regulatory, Manufacturing Operations and R&D to embed quality into the product lifecycle.

The role requires 10+ years in medical device quality with a BS in Biomedical Engineering; MS preferred.

Qualifications

• Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
• Background in quality system elements across product lifecycle.
• Proven ability to lead audits and CAPA programs.
• Strong analytical and problem-solving skills.

Responsibilities

• Collaborate with Regulatory, Manufacturing Ops, and R&D to support QMS and core processes.
• Lead CAPA, NCRs, MRB, internal audits, and management reviews.
• Plan and execute supplier audits and inspection readiness activities.
• Support FDA inspections and Notified Body audits.
• Evaluate and validate modern analytical tools and quality metrics.
• Harmonize quality KPIs across sites globally.
• Provide technical guidance to quality specialists and junior engineers.
• Ensure traceability and documentation across QMS records.

Skills

Quality Systems

Quality Engineering

Regulatory knowledge

CAPA

Audit experience

Cross-functional collaboration

Statistical techniques

Documentation skills

Project management

Problem solving

Education

Bachelor of Science in Biomedical Engineering

Master of Science preferred

Job description

Jenavalve Technology Inc in Irvine, CA seeks a Principal Engineer, Quality Systems to lead CAPA, NCRs, change control, audits, and QMS improvements for medical devices under FDA 21 CFR 820 and ISO 13485. You will collaborate across Regulatory, Manufacturing Operations and R&D to embed quality into the product lifecycle.

The role requires 10+ years in medical device quality with a BS in Biomedical Engineering; MS preferred.