Quality Assurance Engineer

TalenTier; Austin (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

TalenTier is seeking a Quality Assurance representative to support product development in Austin, Texas. The role involves ensuring compliance with quality systems and regulatory standards, as well as leading audits and analyses of device failures. Candidates must have a Bachelor’s degree in Biomedical or Mechanical Engineering and 5+ years of experience in quality or product development. Proficiency in Microsoft Office and knowledge of ISO regulations are preferred qualifications.

Qualifications

• 5+ years experience in quality or product development.
• Experience in a regulated industry (medical device, aerospace, automotive).
• Knowledge of ISO 13485 and ISO 14971 risk management.

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.

Skills

Quality Assurance

Risk Analysis

Regulatory Compliance

Internal Audits

Data Analysis

Education

Bachelor’s degree in Biomedical or Mechanical Engineering

Tools

Microsoft Office

SolidWorks

Oracle R12

Agile PLM

Job description

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