Job Description

Location: 571 Silveron Blvd, Flower Mound, TX

Shift: Monday - Friday, day shift hours ( flexible )

Quality Engineer Technician, Calibration Coordinator

Summary:

The Quality Engineer Technician, Calibration Coordinator, will be responsible for managing the calibration program, ensuring compliance with industry regulations and company standards. In this role, you will track calibration schedules, coordinate external calibration services, maintain and update calibration procedures, and support internal and external audits. You will also collaborate with New Product Development (NPD) teams to ensure the existing toolset remains compatible with future products, as well as other tasks needed to support the business.

Additionally, you will be assisting the Quality Engineering team in developing, applying, revising, and maintaining quality standards for processing returned materials, components, and finished products. Responsible to perform root cause product investigation and disposition product.

What You Will Do:

• Work as a member of the Returns team to receive, investigate, inspect, test, and disposition incoming product.
• Maintain an accurate inventory of calibrated tools.
• Track and schedule calibrations using CERDAAC software & Agile database to ensure timely compliance.
• Coordinate with external calibration service providers and manage calibration-related documentation.
• Verify and maintain calibration and operation of all tools, maintain equipment logs, and complete maintenance reports accurately.
• Develop, update, and enforce calibration procedures to comply with ISO 13485:2016, FDA regulations, and NIST traceability requirements.
• Serve as the primary point of contact for internal and external auditors regarding calibration program compliance.
• Serve as the primary point of contact for all field-based personnel regarding calibration program escalations.
• Collaborate with NPD teams to assess tool compatibility with new products and recommend necessary updates.
• Various special duties as assigned within the Quality organization.

What You Need:

Required:

• High School Diploma or equivalent
• 3+ years of experience in calibration, quality systems, or a similar role in the medical device or regulated industry
• Knowledge of ISO 13485, FDA regulations, and NIST traceability requirements
• Experience with troubleshooting and repair fundamentals
• Ability to work with and inspect very small objects, component parts, and tools
• Ability to push, pull, lift, carry, etc. up to 40 lbs.
• Ability to analyze and resolve non-routine product issues using independent judgment and inspection equipment.

Preferred:

• Associate of Science in Engineering or Engineering-related discipline
• Quality Assurance training

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