Quality Control Manager

Plano, United States | Posted on 06/01/2025

Ultrahuman is the world's most comprehensive self‑quantification platform. Ultrahuman’s products include the Ultrahuman Ring AIR, world’s lightest sleep‑tracking wearable, Ultrahuman M1, a continuous glucose monitoring platform, Blood Vision, a preventive blood testing platform with the pioneering Ultra Trace™ technology and Ultrahuman Home, a revolutionary health device for your home. By collating a large set of biomarkers on an integrated platform, Ultrahuman is able to create a grand unified view of the human body.

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Job Summary:

North America remains a key region for Ultrahuman, and maintaining world‑class quality standards is essential to our continued success. As the Quality Control Manager, you will play a mission‑critical leadership role in ensuring every unit we manufacture meets the highest benchmarks for performance, reliability, and safety. This role demands a proactive leader who can seamlessly blend strategy with execution, someone who sees the full scope of our quality ecosystem while actively working alongside cross‑functional teams to improve it.

You’ll collaborate closely with our India‑based operations, Process Engineering, Production, and Supply Chain to build and refine quality systems that scale with our growth. Just as industry leaders have redefined expectations through rigorous standards and relentless focus, you’ll help position Ultrahuman as a quality‑first brand in the health tech space. By applying first‑principles thinking and driving continuous improvement, you’ll instil a culture of excellence and accountability across our manufacturing operations.

Your leadership will be key to delivering superior products that our customers trust, unit after unit, day after day.

• Define and execute in‑process and final QC strategies: develop comprehensive quality control plans and procedures that encompass all stages of the manufacturing process, from raw material inspection to final product release. This includes establishing acceptance criteria, sampling plans, and testing methodologies to ensure products meet or exceed specified quality requirements.
• Lead root cause analysis and drive corrective actions (CAPA): take ownership of investigating quality issues, identifying root causes through systematic analysis, and implementing effective corrective and preventive actions. This involves leading cross‑functional teams in problem‑solving efforts, documenting findings, and verifying the effectiveness of implemented solutions to prevent recurrence.
• Manage inspection protocols, test plans, and quality documentation: oversee the creation, maintenance, and execution of detailed inspection protocols, comprehensive test plans, and accurate quality documentation. This includes ensuring that all quality‑related records are complete, accurate, and readily accessible, adhering to regulatory requirements and internal standards.
• Work with suppliers on incoming part quality: collaborate closely with suppliers to establish and maintain high‑quality standards for incoming components and materials. This involves defining quality requirements, conducting supplier audits, monitoring supplier performance, and addressing any quality issues to ensure the integrity of the supply chain.
• Maintain compliance with ISO and FDA standards (as applicable): ensure ongoing compliance with relevant international standards, such as ISO 9001 and ISO 13485, as well as applicable regulatory requirements, such as those set forth by the Food and Drug Administration (FDA) for medical devices. This includes participating in audits, implementing necessary procedures, and maintaining a state of audit readiness.

• 5–8 years in QC or QA roles in medical devices, wearables, or electronics: possess a minimum of 5 to 8 years of progressive experience in Quality Control or Quality Assurance roles within the medical device, wearable technology, or electronics manufacturing industries.
• Knowledge of statistical process control and quality tools: demonstrate a solid understanding and practical application of statistical process control (SPC) methodologies and various quality management tools, such as control charts, Pareto analysis, fishbone diagrams, and failure mode and effects analysis (FMEA).
• Familiarity with ISO 9001, ISO 13485, or similar: possess a strong working knowledge of ISO 9001 and ISO 13485 quality management system standards, or comparable industry‑specific quality standards.
• Experience with precision components and high‑mix low‑volume production: have hands‑on experience working with precision‑engineered components and managing quality control processes in a high‑mix, low‑volume production environment.