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Quality Assurance Engineer
Job in
Austin, Travis County, Texas, 78716, USA
Listed on 2026-04-28
Listing for:
TalenTier
Full Time
position Listed on 2026-04-28
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Reports To: Design Quality Engineering Manager
Position SummaryResponsible for supporting product development teams by implementing and maintaining quality systems that ensure compliance with company standards and regulatory requirements. Serves as the Quality Assurance representative during product development and sustaining engineering activities.
Key Responsibilities- Support new product development (NPD) and sustaining engineering projects
- Participate in design and manufacturing reviews
- Develop and maintain risk analyses (DFMEA / UFMEA)
- Review and approve design and development documentation
- Serve as design quality subject matter expert during ISO and FDA audits
- Author quality procedures and work instructions
- Conduct internal quality system audits
- Evaluate and disposition nonconforming materials
- Ensure compliance with GMP, ISO, FDA, and other regulatory standards
- Analyze device failures, complaints, and quality trends
- Lead Corrective and Preventive Actions (CAPA) and support Health Hazard Evaluations
- Bachelor’s degree in Biomedical or Mechanical Engineering
- 5+ years experience in quality or product development
- Experience in a regulated industry (medical device, aerospace, automotive)
- Proficiency in Microsoft Office
- Knowledge of ISO 13485 and ISO 14971 risk management
- Experience with Solid Works, Oracle R12, Agile PLM
- CQE, Lean, or Six Sigma certification preferred
- Understanding of precision manufacturing and sterilization processes
Position Requirements
5+ Years
work experience
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