Associate QA Specialist

Position Summary:

Hybrid- Either San Carlos, CA or Austin, TX. office location.

 

Under direct supervision, the Associate Quality Assurance Specialist supports the Quality team in executing daily quality operations, including documentation review, audit support, and administrative oversight of quality system processes. The individual will gain exposure to regulations such as FDA, ISO13485, CLIA, and CAP and will expand their knowledge through hands-on duties, training, and mentoring.

 

Primary Responsibilities:

•    Collect and trend quality metrics under supervision
•    Provide administrative support for CAPAs, Deviations, SCARs, Complaints, and NCRs
•    Support document review, qualification record tracking, and audit preparation
•    Assist with scheduling and logistics for internal audits
•    May serve as scribe or support during internal and external audits
•    Help maintain training records and employee credential tracking
•    Coordinate with IT for user access to eQMS and training systems
•    Perform other duties as assigned