QA Engineer I
On-siteAustin, Texas, United States
Job Summary
Maintain and continuously improve the Quality Management System (QMS) while ensuring document and records control activities are performed accurately. Collaborate with Manufacturing, Supply Chain, and Customer Service teams to support documentation requests like Certificates of Analysis and Certificates of Conformance. Coordinate change control activities, support audits by ensuring quality records are complete, and generate quality system metrics and KPIs. Participate in quality improvement projects, process enhancements, and investigations including corrective and preventive actions. Perform other quality systems duties as assigned. This role requires adherence to GMP, ISO13485, FDA 21CFR Part 820, and other regulatory standards.
Required Qualifications
- 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
- Bachelor's degree in life sciences, engineering, process engineering, chemistry, biotechnology, or related sciences
- 1+ years of work experience in Quality Assurance/Quality Systems role
- Experienced working in ISO 9001, ISO 13485, USDA, and/or GMP environments
- Strong computer skills (Office, Project, Teams, Visio, Word, Excel)
- Experience in E1, SAP, Agile, TrackWise, and Power BI
- Advanced computer skills
- 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
Desired Qualifications
- Bachelor's degree in life sciences, engineering, process engineering, chemistry, biotechnology, or related sciences preferred
- 1+ years of work experience in Quality Assurance/Quality Systems role preferred
- Experienced working in ISO 9001, ISO 13485, USDA, and/or GMP environments
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