Quality Assurance Technician Sr

What You Can Expect

As an R&D Quality Control Technician, you will play a critical hands-on role in supporting product development by inspecting prototypes and maintaining the accuracy and capability of the R&D metrology laboratory.
This position is full-time onsite in Austin, Texas, supporting cross-functional engineering teams with precision measurement and quality inspection expertise.

How You'll Create Impact

• Perform incoming, in-process, and final QC inspection of R&D prototypes and development builds
• Conduct dimensional inspections using metrology tools such as:
  • Calipers, micrometers, height gauges
  • Faro arm
• Interpret engineering drawings, GD&T, and specifications to verify prototype conformance
• Generate and document inspection reports, measurement data, and nonconformance records
• Maintain and manage the R&D metrology lab, including:
  • Equipment setup, qualification, and maintenance
  • Calibration scheduling and tracking
  • Environmental monitoring as required
• Support development teams with measurement data analysis and feedback
• Assist in method development and improvement of inspection processes
• Ensure compliance with quality system requirements and documentation standards
• Support internal audits and continuous improvement initiatives

What Makes You Stand Out

• Strong proficiency with precision measurement tools and inspection techniques
• Solid understanding of GD&T and blueprint reading
• Experience operating metrology equipment
• High attention to detail and data accuracy
• Ability to work in a fast-paced R&D environment with evolving designs
• Strong documentation and organizational skills
• Team-oriented mindset with effective communication skills
• Basic knowledge of statistical methods and inspection data analysis

Applicable Regulatory & Consensus Standards

• Ensure compliance with FDA and EU MDR requirements by applying relevant recognized consensus standards for medical robotic systems and SiMD, including:
  • Quality & Risk Management
    • ISO 13485 – Medical Device Quality Management Systems
    • ISO 14971 – Application of Risk Management to Medical Devices
  • Software & SiMD
    • IEC 62304 – Medical Device Software Lifecycle Processes
    • FDA Guidance on Software as a Medical Device (SaMD) and cybersecurity
    • IEC 82304-1 – Health software product safety
  • Usability & Human Factors
    • IEC 62366-1 – Usability Engineering
  • Electrical & System Safety
    • IEC 60601-1 – General Requirements for Basic Safety and Essential Performance
    • IEC 60601-1-2 – Electromagnetic Compatibility
    • IEC 60601-1-6 – Usability (aligned to IEC 62366)
  • Robotics & Complex Electromechanical Systems
    • ISO 10218-1 / 10218-2 – Safety Requirements for Industrial Robots (as applicable to collaborative systems)
    • IEC 80601 (where applicable for medical electrical equipment systems)
  • EU MDR Compliance
    • Regulation (EU) 2017/745 (MDR) – General Safety and Performance Requirements (GSPR)
    • MEDDEV & MDCG guidance (clinical evaluation, software qualification, cybersecurity)

Your Background

• Minimum Requirements: High School Diploma or Equivalent with specialized training and/or certification and 4 years of relevant experience
• Highly Preferred Education and Experience:
  • Associate degree or technical certification in Manufacturing, Quality, Engineering Technology, or related field
  • 2+ years of experience in quality control, inspection, or metrology (medical device experience preferred)
  • Experience with prototype inspection or R&D environments is highly desirable
  • Familiarity with ISO 13485 and quality system documentation

Travel Expectations

Up to 10%

Expected Compensation Range

$27.00 - $34.00/hr USD