Principal Quality Systems Engineer - Global Compliance

Jenavalve Technology; Irvine (CA); On-site; USD 149,000 - 182,000; Full time

Job summary

Jenavalve Technology is seeking a Principal Engineer, Quality Systems in Irvine, CA. You will drive Quality Systems and Quality Engineering tasks across new product development and commercialization, ensuring compliance with FDA, ISO, EU MDR, and MDSAP, while aligning with business goals.

The role includes leading CAPA, NCRs, change control, management reviews, and quality metrics, with a focus on automation, digital transformation, and supplier audits.

Qualifications

• Bachelor of Science in Biomedical Engineering or equivalent required.
• Master of Science degree preferred.
• 10+ years of experience in medical device or pharmaceutical industry or MS + 8 years of experience.

Responsibilities

• Collaborate with Regulatory, Manufacturing Operations, and R&D to support QMS and core processes.
• Lead quality system activities including CAPAs, NCRs, MRB, audits, and quality metrics.

Skills

Quality Systems

Quality Engineering

Statistical methods

Cross-functional teamwork

Project management

Regulatory knowledge

Problem solving

Education

Bachelor of Science in Biomedical Engineering

MS preferred

Job description

Jenavalve Technology is seeking a Principal Engineer, Quality Systems in Irvine, CA. You will drive Quality Systems and Quality Engineering tasks across new product development and commercialization, ensuring compliance with FDA, ISO, EU MDR, and MDSAP, while aligning with business goals.

The role includes leading CAPA, NCRs, change control, management reviews, and quality metrics, with a focus on automation, digital transformation, and supplier audits.