QA Specialist II: Batch Release & Quality Systems Expert

REVA Medical, Inc.; San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

REVA Medical, Inc. is seeking a Quality Assurance Specialist in San Diego. The role independently owns defined QA processes, supports regulatory activities, and leads process improvements in collaboration with QA staff and Sr. Quality Systems Engineer.

The ideal candidate will drive batch release, manage quality events, support FDA submissions, and contribute to risk management and eQMS initiatives while ensuring compliance across the quality system.

Qualifications

• Bachelor's degree required in a scientific, engineering, technical, or related discipline (medical device preferred).
• 3–5 years QA/Regulatory Affairs experience in a regulated industry preferred.
• Familiarity with ISO 13485 and 21 CFR Part 820 strongly preferred.

Responsibilities

• Own and manage batch release activities per approved procedures and regulatory requirements.
• Triage and investigate quality events (NCMR, deviation, CAPA) and drive timely closure.
• Support FDA submissions, Notified Body audits, ISO 13485 and supplier/customer audits.
• Lead or support risk management activities and cross-functional quality-system improvements.
• Coordinate document control, training, and eQMS-related activities with QA Associate.
• Develop and analyze quality metrics; communicate trends to management.
• Provide training and guidance on QA processes to operations and development teams.

Skills

ISO 13485

21 CFR Part 820

ISO 14971

Root cause analysis

CAPA

NCMR/Deviations

Audit support

eQMS

Cross-functional collaboration

Quality Metrics

Documentation & training

Risk management

Batch release

Data analysis

Verbal/written communication

Education

Bachelor's degree in science/engineering/technical field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

eQMS

Job description

REVA Medical, Inc. is seeking a Quality Assurance Specialist in San Diego. The role independently owns defined QA processes, supports regulatory activities, and leads process improvements in collaboration with QA staff and Sr. Quality Systems Engineer.

The ideal candidate will drive batch release, manage quality events, support FDA submissions, and contribute to risk management and eQMS initiatives while ensuring compliance across the quality system.