Quality Assurance Technician Sr
Zimmer Biomet · Austin, Texas ·
- Seniority
- Senior
- Employment
- Full time
- Category
- QA
- Experience
- 2+ years
- Salary
- USD 27 – 34 / hour
Perform precision inspections of medical-device prototypes using calipers, micrometers, and a Faro arm, document results, and maintain the R&D metrology lab to meet ISO 13485 and FDA/EU MDR requirements.
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
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)
- Quality & Risk Management
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
EOE