Zimmer Biomet
Zimmer Biomet

Quality Assurance Technician Sr

职能QA
级别资深
地点Austin, TX, United States
方式现场办公
类型External
发布3周前
立即申请

职位介绍

The Quality Assurance Technician Senior at Zimmer Biomet is responsible for conducting incoming, in-process, and final quality control inspections of R&D prototypes and development builds. The role involves using metrology tools such as calipers, micrometers, and height gauges, interpreting engineering drawings, and maintaining the R&D metrology laboratory. Candidates must have a high school diploma or equivalent, with at least four years of relevant experience, and strong proficiency in precision measurement and inspection techniques. Familiarity with ISO 13485, quality system documentation, and regulatory standards is required. Experience in medical device quality control and prototype inspection is highly desirable. The position is full-time onsite in Austin, Texas, with up to 10% travel. The Quality Assurance Technician SR at Zimmer Biomet plays a vital role in supporting product development by performing precise quality control inspections on prototypes and development builds. This full-time, onsite position in Austin, Texas, involves hands-on measurement and inspection of R&D prototypes, maintaining the accuracy of the metrology laboratory, and ensuring compliance with regulatory standards. The role requires collaboration with cross-functional engineering teams and active participation in continuous improvement initiatives. Candidates will benefit from a supportive environment focused on professional growth, recognition, and a culture of belonging. Compensation and benefits are not specified in the job description.

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)

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%

EOE

  • 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 Responsibilities
  • Perform incoming, in-process, and final quality control inspections of R&D prototypes and development builds.
  • Conduct dimensional inspections using metrology tools such as calipers, micrometers, height gauges, and faro arms.
  • 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 laboratory, including equipment setup, qualification, and maintenance.
  • Schedule and track calibration activities and 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. Skills
  • Strong proficiency with precision measurement tools and inspection techniques is required.
  • Solid understanding of GD&T and blueprint reading is essential.
  • Experience operating metrology equipment is necessary.
  • High attention to detail and data accuracy is expected.
  • Ability to work in a fast-paced R&D environment with evolving designs is important.
  • Strong documentation and organisational skills are required.
  • Team-oriented mindset with effective communication skills is valued.
  • Basic knowledge of statistical methods and inspection data analysis is beneficial.
  • Familiarity with ISO 13485 and quality system documentation is required.
  • Experience in quality control, inspection, or metrology, with medical device experience preferred, is highly desirable. Education
  • A high school diploma or equivalent with specialised training and/or certification is required.
  • An associate degree or technical certification in Manufacturing, Quality, Engineering Technology, or a related field is highly preferred.

必备技能

Facilities maintenance

Troubleshooting

Safety procedures

关于Zimmer Biomet

Austin

总部位置