Quality Systems Engineer - Med Devices Compliance

Jenavalve Technology Inc; Irvine (CA); On-site; USD 110,000 - 190,000; Full time

Job summary

Jenavalve Technology Inc. in Irvine, CA, seeks a Staff Engineer, Quality Systems to lead QA activities across the product lifecycle and ensure compliance with FDA and ISO standards.

You will drive CAPAs, NCRs, audits, and QMS improvements while collaborating with Regulatory, Manufacturing, and R&D teams. The role requires strong documentation, cross-functional communication, and hands-on participation in validation and change control.

Qualifications

• BS in Biomedical Engineering or equivalent; MS preferred.
• Minimum 5+ years in medical device or pharmaceutical industry.
• Experience in regulated manufacturing environments with 21 CFR Part 820, ISO 13485, ISO 14971.

Responsibilities

• Lead Quality System activities including CAPAs and NCRs.
• Support audits (FDA, Notified Bodies) and supplier audits.
• Drive QMS improvements and KPI harmonization across sites.
• Collaborate with Regulatory, Manufacturing and R&D teams.
• Support software validation and change control processes.

Skills

Quality Systems

CAPA

Audits

Documentation

Project Management

Cross-functional Collaboration

Communication

Education

Bachelor's in Biomedical Engineering

MS preferred

Tools

eQMS

Verification/Validation

Job description

Jenavalve Technology Inc. in Irvine, CA, seeks a Staff Engineer, Quality Systems to lead QA activities across the product lifecycle and ensure compliance with FDA and ISO standards.

You will drive CAPAs, NCRs, audits, and QMS improvements while collaborating with Regulatory, Manufacturing, and R&D teams. The role requires strong documentation, cross-functional communication, and hands-on participation in validation and change control.