QA Engineer I

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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division-Specific Information:

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.

Discover Impactful Work:

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.

A Day in the Life:

• 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.

Education and Experience

• 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 & collaborating effectively with internal and external customers.
• Experienced in improving the site’s Quality Management System and promoting site Quality.
• Experienced in working & collaborating with internal and external customers.

Benefits:

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!