Quality Assurance Engineer

Job Title: Quality Assurance Specialist
Location: Austin, TX
Reports To: Design Quality Engineering Manager

Position Summary

Responsible 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

Minimum Qualifications:

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

Preferred Qualifications:

Knowledge of ISO 13485 and ISO 14971 risk management
Experience with SolidWorks, Oracle R12, Agile PLM
CQE, Lean, or Six Sigma certification preferred
Understanding of precision manufacturing and sterilization processes
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