QA Engineer I: Build Quality Systems & Compliance

American Society for Quality; Austin, Northern (TX, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Health insurance

Career development

Job summary

Thermo Fisher Scientific in Austin, TX is seeking a Quality Engineer to establish and maintain quality programs ensuring compliance with ISO 13485, ISO 9001, FDA 21CFR Part 820, USDA, IVDD/IVDR. The role drives product quality and continuous improvement across functions and supports regulatory compliance.

You’ll collaborate with Manufacturing, Supply Chain, and Customer Service to fulfill documentation requests and participate in CAPA, change control, and KPI tracking.

Qualifications

• Bachelor’s degree in life sciences, engineering, chemistry, biotechnology, or related fields; equivalent combinations may be considered.
• 1+ years QA/Quality Systems experience preferred.
• Experience in ISO 9001, ISO 13485, USDA, and GMP environments.
• Strong computer skills: Office, Project, Teams, Visio, Word, Excel; experience in E1, SAP, Agile, TrackWise, and Power BI.

Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS).
• Ensure document and records control activities are performed accurately and per procedures.
• Collaborate with Manufacturing, Supply Chain, and Customer Service to support documentation requests (Certificates of Analysis/Conformance/Origin).
• Coordinate, review, and administer change control activities.
• Support audits and audit readiness with complete, accurate quality records.
• Generate and maintain quality system metrics and KPIs.
• Participate in quality improvement projects and process enhancements.
• Support investigations, corrective actions, and preventive actions.
• Perform other quality systems duties and projects as assigned.

Skills

Root cause analysis

Quality stakeholder coordination

Regulatory compliance

Documentation management

Education

Bachelor’s degree in life sciences or related field

Tools

E1

SAP

Agile

TrackWise

Power BI

Job description

Thermo Fisher Scientific in Austin, TX is seeking a Quality Engineer to establish and maintain quality programs ensuring compliance with ISO 13485, ISO 9001, FDA 21CFR Part 820, USDA, IVDD/IVDR. The role drives product quality and continuous improvement across functions and supports regulatory compliance.

You’ll collaborate with Manufacturing, Supply Chain, and Customer Service to fulfill documentation requests and participate in CAPA, change control, and KPI tracking.