Engineer I, QA

at  Thermo Fisher Scientific

JOB DESCRIPTION

Would you like to be a member of an outstanding team passionate about making a significant impact? Join Thermo Fisher Scientific Inc. as an Engineer I, QA in West Hills, CA! This critical role ensures that our high-quality, innovative medical devices meet required standards before reaching the market. You will play a meaningful part in maintaining detailed device history records (DHR) for audit purposes and ensuring that all products are labeled and inspected with detail.

In the Specialty Diagnostic Group, we focus on improving human healthcare and supporting patients quality of life. We provide diagnostic products for healthcare, clinical and pharmaceutical labs. At our West Hills site, we develop outstanding HLA products for transplant patients and researchers, improving their lives.

• Perform product inspections to ensure conformance to specifications, reviewing production, packaging/labeling, and laboratory documents for final product release.
• Build labels adhering closely to standards and traceability requirements to prevent backorders and ensure compliance.
• Systematically release finished and semi-finished products based on established standards.
• Assemble, handle, scan, and archive DHRs, ensuring legibility and accuracy of electronic storage.
• Participate in Non-Conformance and CAPA investigations, developing solutions to system and procedural issues.
• Maintain SOPs and provide training as needed.
• Generate, identify, and suggest quality/process improvements.
• Assist in writing new or updated operating procedures and work instructions.
• Prepare and present documents for regulatory agency visits and audits.
• Ensure quality, compliance, and safety in all actions under limited supervision and in accordance with applicable laws and company policies.
• Complete required training and implement strict compliance with role-specific procedures.
• Identify, report, and seek correction for workplace deviations promptly, practicing safe and environmentally responsible behaviors.

MINIMUM QUALIFICATIONS

• A Bachelor’s degree or equivalent experience in a biological or related science from an accredited college, along with 1 year of related QA or QC experience in a GMP-regulated environment. Alternatively, a high school diploma with 5 years of relative experience is also acceptable.
• Previous exposure to reviewing and releasing batch records
• Outstanding analytical, prioritization, multi-tasking, and collaboration skills.
• Strong ethics and the ability to work independently without supervision are required.
• Must work effectively on cross-functional teams and possess outstanding written and verbal skills, including capability to present to a broad audience.

WORKING CONDITIONS/PHYSICAL REQUIREMENTS:

Desk work, including long periods of sitting/standing in front of a PC. Non-remote.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Please refer the Job description for details