QA Engineer I

Location: Austin, TX. Relocation assistance is not provided. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screen.

About the role

At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. The role of Quality Engineer will establish and maintain appropriate Quality Systems consistent with ISO13485 and 9001, FDA 21CFR Part 820, USDA, IVDD, and IVDR requirements, assuring compliance to in-house and/or external specifications and standards. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Ensure document and records control activities, including revisions, approvals, issuance, archival, and obsolescence, are performed accurately and in accordance with established procedures.
• Collaborate with Manufacturing, Supply Chain, and Customer Service teams to support customer documentation requests such as preparation and issuance of Certificates of Analysis, Certificates of Conformance, and Certificates of Origin.
• Coordinate, review, and administer change control activities.
• Support audits and audit readiness by ensuring quality records are complete, accurate, and readily accessible.
• Generate, collect, compile, and maintain quality system metrics and key performance indicators (KPIs).
• Participate in quality improvement projects and process enhancement initiatives.
• Support investigations, corrective actions, and preventive actions.
• Perform other quality systems duties and projects as assigned.

Requirements

• Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology, or related sciences preferred (equivalent combinations of education and direct quality work experience may be considered).
• 1+ years of work experience in Quality Assurance/Quality Systems role preferred.
• Experienced working in ISO 9001, ISO 13485, USDA, and/or GMP environments.
• Strong computer skills (Office, Project, Teams, Visio, Word, Excel) and experience in E1, SAP, Agile, TrackWise, and Power BI. Advanced computer skills preferred.
• Experienced with Quality tools, methodologies, and complaint investigations, including root cause analysis.
• Experienced in working and collaborating effectively with internal and external customers.
• Experienced in improving the site’s Quality Management System and promoting site Quality.

Schedule

Standard (Mon-Fri)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Office environment.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus.
• Healthcare.
• A range of employee benefits.
• Employment with an innovative, forward-thinking organization and outstanding career and development prospects.
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.