Quality Assurance Associate

REVA Medical, LLC.; San Diego (CA); On-site; USD 33,000 - 45,000; Full time

Job summary

REVA Medical, LLC. in San Diego, CA seeks a QA Associate to support the Quality Management System through document control, training administration, and asset maintenance. You will ensure record accuracy, track due dates, and escalate issues per procedures, collaborating with QA specialists on cross-training and backup support.

The role emphasizes maintaining logs, facilitating eQMS workflows, and supporting audits and batch release activities with meticulous attention to detail.

Qualifications

• Bachelor's degree or equivalent in a scientific, technical, business, or related discipline.
• 0–2 years of Quality Assurance, document control, or regulated manufacturing experience.
• Familiarity with ISO 13485 and 21 CFR Part 820 is desirable.
• Strong attention to detail and ability to manage multiple due dates.

Responsibilities

• Administer day-to-day document control activities, routing changes and archiving records.
• Maintain controlled Quality System documents and records (SOPs, forms, specs).
• Support training system: assignment, tracking, overdue training follow-up.
• Manage equipment calibration and preventive maintenance records and scheduling.
• Support quality system records for audits and CAPA, deviation, and batch release activities.

Skills

Attention to detail

Communication skills

Cross-training

Backup support

Team collaboration

Education

Bachelor's degree in a scientific, technical, business, or related discipline

Tools

Microsoft Word

Excel

PowerPoint

eQMS

Job description

Job Purpose

The Quality Assurance Associate supports the effective operation of the Quality Management System through accurate and timely administration of document control, training, equipment calibration/preventive maintenance, and related quality records. The position is responsible for executing established quality system processes, maintaining required logs and records, monitoring routine due dates, and escalating issues in accordance with approved procedures.

The QA Associate works collaboratively with the QA Specialist and Sr. Quality Systems Engineer. The roles are expected to coordinate closely and provide cross-training and backup support for assigned processes; however, the QA Associate does not report to the QA Specialist. The position operates under departmental management and escalates quality decisions requiring independent technical or compliance judgment.

Document Control & Records Administration

• Administer day-to-day document control activities, including processing document change requests, routing documents for review and approval, issuing effective documents, maintaining controlled copies, and archiving superseded records in accordance with approved procedures.
• Perform document quality control checks for formatting, required approvals, metadata, references, and completeness; promptly communicate irregularities and coordinate correction prior to release.
• Maintain controlled Quality System documents and records, including SOPs, Work Instructions, forms, specifications, drawings, batch records, protocols, reports, and other applicable technical documentation.
• Support authors and process owners with document templates, document numbering, routing requirements, and document control procedures.
• Maintain external standards and regulatory reference records applicable to manufacturing, quality, and design activities.
• Support document migration and data verification activities associated with implementation and maintenance of the electronic Quality Management System (eQMS).

Training Administration

• Administer the training system, including assignment of required training, maintenance of training curricula and records, tracking of completion, and follow-up on overdue training.
• Coordinate training assignments resulting from new or revised controlled documents and verify completion before or following document effective dates as required by procedure.
• Support preparation of training status reports and escalate overdue or incomplete training to responsible managers and Quality management.
• Provide routine user support for the training system and assist with eQMS training administration.

Asset Management – Calibration & Preventive Maintenance

• Administer the equipment calibration and preventive maintenance program, including maintenance of the asset database, scheduling, due-date tracking, and coordination with internal personnel and outside service providers.
• Collect and maintain calibration, preventive maintenance, qualification, and service records and perform defined administrative/documentation checks for completeness.
• Monitor upcoming and overdue calibration and preventive maintenance activities and escalate overdue, missing, or potentially non-conforming equipment records to the QA Specialist, Sr. Quality Systems Engineer, or Quality management as appropriate.
• Support equipment status labeling and other routine asset-control activities in accordance with approved procedures.

Quality System Support

• Maintain quality system logs and trackers and support collection of data used for quality metrics and Management Review.
• Provide administrative support for NCMR, deviation, CAPA, complaint, audit, and other quality system records, including record initiation, routing, tracking, filing, and follow-up as assigned.
• Support batch release activities through record compilation, document verification, and other assigned activities performed in accordance with approved procedures and authorization levels.
• Retrieve records and documentation in support of internal, external, customer, Notified Body, and FDA audits or inspections.
• Support implementation, migration, testing, and ongoing administration of eQMS workflows in coordination with the QA Specialist and Sr. Quality Systems Engineer.
• Identify recurring administrative issues or opportunities for process improvement and communicate them to process owners and Quality management.
• Provide backup support for defined QA Specialist activities when trained and authorized.
• Perform other duties and quality projects as assigned.

Skills / Qualifications

• Bachelor's degree in a scientific, technical, business, or related discipline preferred; relevant education and experience may be accepted in lieu of a degree.
• 0–2 years of experience in Quality Assurance, document control, regulated manufacturing, or a related function preferred. Medical device or pharmaceutical experience is desirable.
• Basic knowledge of, or ability to learn, ISO 13485 and 21 CFR Part 820 (Quality Management System Regulation/QMSR). Exposure to 21 CFR Parts 210/211 and Part 4 for combination products is desirable.
• Strong attention to detail and demonstrated ability to maintain accurate records, manage multiple due dates, and follow established procedures.
• Strong written and verbal communication skills and ability to coordinate effectively with employees at all organizational levels.
• Proficiency with Microsoft Word, Excel, PowerPoint, and electronic document or quality management systems; eQMS experience preferred.
• Ability to recognize and escalate discrepancies, overdue activities, or situations requiring Quality review.
• Positive, collaborative, and dependable working style with willingness to cross-train and provide backup support across Quality Assurance activities.

Salary: $24.00 - $33.00 per hour