Quality Systems Engineer I: Drive Compliance & Innovation

Jenavalve Technology; Irvine (CA); On-site; USD 117,000 - 143,000; Full time

Job summary

Jenavalve Technology in Irvine, CA is seeking a Staff Engineer, Quality Systems to lead quality engineering activities for new product development and commercialization in compliance with FDA 21 CFR 820, ISO 13485, EU MDR and MDSAP.

The role collaborates with Regulatory, Manufacturing Operations and R&D to strengthen the QMS, manage CAPAs, NCRs, change control, audits and quality metrics, and to drive digital tools and process improvements.

Qualifications

• Bachelor's degree in Biomedical Engineering or equivalent is required; master's preferred.
• Quality engineering experience in medical devices or pharma is required.
• Direct experience with regulated manufacturing and knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 is essential.

Responsibilities

• Collaborate with Regulatory, Manufacturing Operations, and R&D to support the QMS, eQMS enhancements, and validation activities.
• Lead Quality System activities including CAPAs, NCRs, MRB, internal audits, and management reviews.
• Support FDA inspections, Notified Body audits, supplier audits, and audit findings closure.
• Support tech innovation and digital transformation by evaluating and implementing modern analytical tools and automation.
• Lead harmonization of quality KPIs across sites globally and guide software validation efforts.

Skills

Quality Engineering

Regulatory compliance

Cross-functional collaboration

Documentation

Project management

Risk management

Education

Bachelor's degree in Biomedical Engineering or related

Master's degree preferred

Tools

eQMS

CAPA processes

Audit management

Job description

Jenavalve Technology in Irvine, CA is seeking a Staff Engineer, Quality Systems to lead quality engineering activities for new product development and commercialization in compliance with FDA 21 CFR 820, ISO 13485, EU MDR and MDSAP.

The role collaborates with Regulatory, Manufacturing Operations and R&D to strengthen the QMS, manage CAPAs, NCRs, change control, audits and quality metrics, and to drive digital tools and process improvements.