Quality Specialist, Entry Level
Austin, Texas

Entry Level Contract Quality Specialist needed to review production records and assist with non-conformance management, incumbent will also support quality and training documentation. Technical and quality expertise within an FDA-regulated, ISO 13485 environment preferred, and emphasizes operational excellence and regulatory compliance.

This is an entry level position, client prefers a Contract to Hire (for speed to hire purposes).

Summary:
Working collaboratively with Operations, Manufacturing, and Engineering teams, the Quality Inspector focus on supporting the transfer of manufacturing processes, quality documentation, and ensuring alignment with FDA and ISO standards.

Key Responsibilities:
Ensure all quality inspection activities follow FDA QSR (21 CFR 820), ISO 13485, and relevant global medical device standards.
Review, update, and verify device history records, work instructions, vali...