RA/QA Engineer

TL;DR

RA/QA Engineer (Medical Devices): Design, implement, and maintain quality assurance procedures for new and sustaining product development with an accent on compliance with ISO, FDA, and other regulations. Focus on risk analysis, audits, corrective actions, and supporting design/manufacturing reviews.

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.