Quality Engineering Specialist; Entry Level

Quality Engineering Specialist (Entry Level)

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, validation protocols, and training certification documents for the new site.
• Collaborate with R&D, Operations, Manufacturing, Regulatory, and Quality Assurance teams to facilitate the successful transfer of quality systems and training materials.
• Update and maintain training documentation and assist with internal audits during the transition period.
• Maintain meticulous records and use strong technical writing skills while managing risk throughout the process.
• Assist with the review and approval of engineering change orders, nonconformances, and CAPAs as required.

Qualifications:

0-3 years experience in a fast-paced manufacturing environment with changing priorities. 0-3 years of quality assurance or quality inspection experience, or manufacturing documentation. Medical device, diagnostic, or biotechnology industry, and/or FDA familiarity preferred. Associates or Bachelor's degree in life sciences (Biology, chemistry, biochemistry or similar) preferred. Knowledge of FDA QSR (21 CFR 820), ISO 13485, quality documentation, design controls, validation, and CAPA processes.

Skilled in data analysis, risk management, deviation handling, technical writing, and audit support. Excellent communication and teamwork skills; consistent attention to detail. Commitment to operational and regulatory priorities over titles or manufacturing-only background.

About our Client:
Client is a global leader in diagnostic solutions, combining over 50 years of scientific and technological innovation to develop trusted diagnostic assays and instruments. Our products are used worldwide to improve patient care and clinical outcomes.