Senior QA Specialist — Batch Release & CAPA

REVA Medical, LLC.; San Diego (CA); On-site; USD 75,000 - 90,000; Full time

Job summary

REVA Medical, LLC. is seeking a Quality Assurance Specialist to own defined QMS processes, drive timely resolution of quality events, and support regulatory activities in a medical-device setting.

You will collaborate with QA teams and cross-functional groups to ensure product disposition, data-driven improvements, and compliance across ISO 13485, 21 CFR 820, and risk management activities.

Qualifications

• Experience owning defined QMS processes within a regulated industry.
• Familiarity with ISO 13485 and 21 CFR Part 820 requirements.
• Strong problem-solving, documentation, and communication skills.

Responsibilities

• Own batch release activities and maintain compliance with procedures and regulatory requirements.
• Lead investigations, CAPA, NCMR, and risk management activities with cross-functional teams.
• Support regulatory submissions, audits, and inspection readiness.
• Maintain calibration/asset management processes and eQMS documentation.
• Analyze quality metrics and drive system improvements across functions.

Skills

QMS ownership

CAPA & NCMR

Root Cause Analysis

Documentation control

Audits & inspections

Metrics & data analysis

Education

Bachelor's degree in science/engineering

Tools

eQMS

Job description

REVA Medical, LLC. is seeking a Quality Assurance Specialist to own defined QMS processes, drive timely resolution of quality events, and support regulatory activities in a medical-device setting.

You will collaborate with QA teams and cross-functional groups to ensure product disposition, data-driven improvements, and compliance across ISO 13485, 21 CFR 820, and risk management activities.