QA Engineer I

Thermo Fisher Scientific•Austin, TX

16h•Onsite

About The Position

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. 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.

Requirements

Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology, or related sciences required.
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.
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.

Nice To Haves

Advanced computer skills preferred.

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.