Quality Engineer

Contract Quality Engineer (FDA-Focused, Manufacturing Transfer)

(Austin, Texas)

Our client is Austin, Texas has an urgent need for a Contract Quality Engineer to assist team transferring Quality and Training documentation to a new facility.  This position is a Contract without an end date, the right motivated candidate will be encouraged, groomed for Direct Hire. 

The Contract Quality Engineer will provide technical and quality support for manufacturing operations within an FDA-regulated, ISO 13485 medical device environment. The role primarily focuses on supporting the transfer of manufacturing processes, quality systems, and training certifications to a new site. Operational excellence and FDA compliance are top priorities.  Experience reviewing and approving engineering change orders, nonconformances, CAPAs essential.

SUMMARY:

Working with Operations, Manufacturing and Engineering team, the Quality Engineer will be responsible for supporting and maintaining quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing and development environment. This role ensures compliance with applicable regulatory requirements, including U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO 13485, and other global standards governing medical devices and diagnostic products.

Quality Engineers apply technical knowledge to support product lifecycle processes, including design controls, risk management, process validation, and production quality. This role partners cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure product quality and continuous improvement.

Key Responsibilities:

Assist in transferring manufacturing operations, quality processes, and documentation (including device history records and SOPs) to a new site.

Prioritize FDA regulatory requirements and maintain alignment with FDA QSR (21 CFR 820), ISO 13485, and similar standards in all quality and operational activities.

Develop and revise device history records, work instructions, validation protocols, and training certification documents for the new site.

Collaborate closely with R&D, operations, manufacturing, regulatory, and quality teams to execute transfer goals.

Support Design & Site Transfer (DSR) activities and facilitate effective onsite training.

Update training documentation and participate in internal audits as-needed during the transition.

Maintain accurate records, apply exceptional technical writing skills, and manage risk throughout the process.

Qualifications:

Bachelor’s degree in life sciences, engineering, or related field preferred.

2–10 years of quality assurance experience in medical device, diagnostic, or biotechnology industry with proven FDA experience.

Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, design control, CAPA, validation, and quality documentation.

Experience in manufacturing site transfers, device history record development, and training certification documentation.

Excellent skills in data analysis, risk management, deviation handling, technical writing, and audit support.

Strong communication and teamwork abilities; attention to detail required.

Able to prioritize operations and regulatory compliance over job titles or manufacturing-only experience.

Comfortable working in large teams; leadership of the entire transfer is not expected.

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.

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