Quality Systems Engineer – CAPA, Audits & Compliance

Jenavalve Technology; Irvine (CA); On-site; USD 73,000 - 90,000; Full time

Job summary

Jenavalve Technology in Irvine, CA is seeking an Engineer, Quality Systems to support quality systems elements including audits, CAPA, nonconformance, and metrics throughout the product lifecycle.

You will collaborate with Regulatory, Manufacturing, and R&D to drive eQMS enhancements, process improvements, and readiness for FDA and international standards. The role requires a BS in engineering and 2+ years in medical device or life sciences quality.

Qualifications

• BS in engineering or relevant scientific field.
• 2+ years in medical device, pharmaceutical, or life sciences tech.

Responsibilities

• Collaborate with Regulatory, Manufacturing Operations, and R&D to support the Quality Management System and core processes, eQMS enhancements and validation activities, and ensure QMS requirements are embedded through product lifecycle.
• Promote proactive quality culture and support training on quality system fundamentals and practices across Quality and cross-functional groups.
• Lead gap assessments to support quality and compliance initiatives and compliance strategy
• Support evaluation of new and revised FDA guidance and international standards for applicability to commercial products.
• Partner with Regulatory Affairs and cross-functional teams in R&D and Operations to ensure requirements are correctly interpreted and implemented.
• Support or lead root cause analysis investigations for quality-related nonconformances and develop and aid in the implementation of effective corrective and/or preventive actions.
• Support FDA inspections, Notified Body audits, and internal audits, including investigation and timely closure of audit findings.
• Support technology innovation and digital transformation initiatives by evaluating and implementing modern analytical tools, automation, and advance quality monitoring systems.
• Support harmonization of quality KPIs across all sites globally

Skills

Quality Systems

Regulatory Compliance

Standards Management

Risk Management

Cross-functional collaboration

Education

Bachelor of Science in Engineering

Tools

eQMS

Job description

Jenavalve Technology in Irvine, CA is seeking an Engineer, Quality Systems to support quality systems elements including audits, CAPA, nonconformance, and metrics throughout the product lifecycle.

You will collaborate with Regulatory, Manufacturing, and R&D to drive eQMS enhancements, process improvements, and readiness for FDA and international standards. The role requires a BS in engineering and 2+ years in medical device or life sciences quality.