RA/QA Engineer

Location: USA, Texas, Austin (onsite full-time)

Company

Innovation-driven medical technology growth company developing clinically differentiated solutions for orthopedics and active lifestyles.

What you will do

• Support sustaining and special instrument teams in design and manufacturing reviews.
• Generate DFMEAs/UFMEAs and participate in risk analysis discussions.
• Review and approve design/development documentation; serve as SME for ISO/FDA audits.
• Author quality procedures/work instructions and conduct internal audits.
• Evaluate nonconforming material, lead CAPA, and review failure trends from complaints.
• Ensure compliance to GMP, ISO, FDA standards and work on special projects.

Requirements

• Bachelor’s in Biomedical or Mechanical Engineering + 2+ years experience.
• Background in medical devices, aeronautics, automotive or regulated industry; ISO13485 knowledge preferred.
• Technical writing skills; basic knowledge of manufacturing processes (metrology, machining, grinding, cleaning, sterilization).
• Microsoft Office proficiency; fluent English (oral/written).
• Up to 10% travel; ability to sit/stand for long periods.
• Knowledge of US/international quality regulations; strong communication/teamwork skills.

Nice to have

• Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
• CQE, Lean, or Six Sigma certification.
• Advanced ISO 14971/risk management knowledge.
• Spanish, German, or French.
• Life sciences quality/regulatory experience (medical devices, pharma, biotech).

Culture & Benefits

• General office environment: clean, orderly, low-moderate noise.
• Culture of continuous improvement, global talent, and innovation.
• Equal employment opportunity based on merit.
• Reasonable accommodations for abilities and beliefs.