Quality Assurance Technician Sr

Zimmer, Inc.•Austin, TX

25d•Onsite

About The Position

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.

Requirements

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
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)
Minimum Requirements: High School Diploma or Equivalent with specialized training and/or certification and 4 years of relevant experience

Nice To Haves

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

Responsibilities

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