Quality Engineering Specialist; On SIte

About Myant:

At Myant, our mission is to help people Live Younger, Longer by transforming healthcare from episodic, reactive care to proactive, preventive health management. Through our pioneering connected textiles and continuous monitoring technology, we bridge the gap between individuals, their families, and healthcare providers—creating a world where quality healthcare is more accessible, personalized, and preventative.

Powered by extensive, multidisciplinary R&D, Myant combines expertise in textile science and computing, biometrics, AI, and clinical research to develop technologies that seamlessly integrate into everyday life. Our innovation engine continuously expands the platform’s capabilities, addressing cardiovascular health, stress management, sleep optimization, and more.

With global ambitions, Myant is building a worldwide presence—collaborating with healthcare systems, clinics, researchers, and partners to set a new standard in connected health. Our goal is not just to improve care, but to fundamentally redefine the relationship people have with their health, shifting the focus from sick care to lifelong wellness.

By combining cutting-edge biometric sensing, AI-powered insights, and evidence-based behavioral coaching, Myant helps individuals and healthcare teams work together to prevent disease, optimize wellness, and unlock healthier, longer lives.

Role Overview:

Myant is a leading innovator in textile-based technology, leveraging advanced materials, smart fabrics, wearable technology and software platforms to transform how people monitor and manage their health and wellness. As Myant continues to scale its medical device manufacturing and expand across North American and European markets, we are seeking a Quality Engineering Specialist to strengthen manufacturing processes, supplier quality and quality systems within a regulated medical device environment.

The Quality Engineering Specialist will provide hands‑on quality engineering expertise across manufacturing, process control, supplier quality, validation, risk management and continuous improvement. The role will help ensure that quality and compliance are embedded throughout the product lifecycle, from design transfer and supplier qualification through manufacturing, inspection, CAPA and ongoing process improvement.

Working cross‑functionally with Operations, Manufacturing, Engineering, Quality, Regulatory and Product teams, the Quality Engineering Specialist will support risk‑based decision‑making and the effective implementation of Quality Management System (QMS) processes in accordance with applicable global regulatory requirements, including ISO 13485, ISO 14971, MDSAP, EU MDR and FDA QMSR.

The successful candidate will bring practical experience within medical device manufacturing and a strong understanding of regulated Quality Management Systems and electronic QMS (eQMS) environments. This individual will be comfortable working hands‑on with technical teams, investigating quality issues, analyzing manufacturing and supplier data, leading root cause investigations and driving corrective and preventive actions.

This is an opportunity for a quality engineering professional who enjoys being hands‑on, solving complex manufacturing problems and working closely with multidisciplinary teams. You will have the opportunity to influence quality from product development and design transfer through manufacturing, supplier management and continuous improvement.

Responsibilities:

• Review, investigate and support the disposition of non-conforming materials, components and devices identified through incoming inspection or active production.
• Support quarantine, containment and disposition…