Senior Quality Engineer — Medical Devices & QMS Lead

Agendia; Irvine (CA); On-site; USD 125,000 - 150,000; Full time

Job summary

Agendia in United States (Irvine) is seeking a QA/RA professional to ensure device quality and regulatory compliance across processes. The role favors strong knowledge of ISO 13485, IVDR, and 21 CFR 820, with supplier quality involvement and CAPA leadership.

You will contribute to post-market surveillance, participate in Design Control, and back-up PRRC responsibilities. Requires 3+ years in medical device QA/RA and relevant certifications.

Qualifications

• Knowledge of ISO 13485, ISO 14971, IVDR and 21 CFR 820.
• Understanding CAP/CLIA requirements is preferred.
• Proficient in quality improvement tools and statistics.

Responsibilities

• Lead quality engineering initiatives across the organization.
• Ensure compliance with FDA/ISO requirements and standards.
• Drive investigations and CAPA with robust data analysis.
• Participate in Design Control and risk management activities.
• Coordinate post-market surveillance and supplier quality.
• Support audits and management review processes.
• Collaborate with supply chain, operations and procurement to improve quality, delivery and cost.

Skills

ISO 13485/14971 knowledge

Regulatory compliance

CAP/CLIA knowledge

Analytical statistics

Quality system standards

Root cause analysis

Project management

Technical presentation

Cross-functional collaboration

Supplier QC/Manufacturing

Education

Bachelor's degree or above in quality/science/engineering

ASQ Quality Engineer/Auditor/Lead Auditor (preferred)

Six Sigma Black Belt (preferred)

Job description

Agendia in United States (Irvine) is seeking a QA/RA professional to ensure device quality and regulatory compliance across processes. The role favors strong knowledge of ISO 13485, IVDR, and 21 CFR 820, with supplier quality involvement and CAPA leadership.

You will contribute to post-market surveillance, participate in Design Control, and back-up PRRC responsibilities. Requires 3+ years in medical device QA/RA and relevant certifications.