21 Oct
|
Myant
|
Winnipeg
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 workplace.
Responsibilities
Manufacturing Quality & Process Control
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 activities in accordance with established procedures and QMS requirements
Lead or support root cause analysis and Corrective and Preventive Action (CAPA) investigations related to recurring assembly, material or manufacturing defects
Develop, implement and maintain appropriate inspection criteria, sampling plans and acceptance criteria for incoming materials, work‑in‑process and finished products
Apply appropriate statistical sampling methodologies, including ANSI/ASQ Z1.4, where applicable
Develop and maintain specialized inspection and testing methods for raw materials, components and finished goods
Monitor manufacturing data, process capability, yields and quality metrics to identify adverse trends before they result in product failures, increased scrap or batch rejection
Support the implementation of Statistical Process Control (SPC) and other data‑driven process control methodologies
Partner with Manufacturing and Operations teams to identify opportunities to improve process capability, yield, reliability and consistency
Provide technical quality support for manufacturing issues and process improvements
Validation, Verification & Risk Management
Review, oversee and approve validation protocols and reports for manufacturing equipment, processes, assembly lines and applicable software systems
Support and/or lead Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities
Develop and maintain quality engineering documentation supporting manufacturing validation and process changes
Lead and facilitate cross‑functional Failure Mode and Effects Analysis (FMEA) activities, with particular emphasis on Process FMEAs (pFMEAs)
Identify, assess and mitigate manufacturing and process‑related risks using risk‑based quality engineering methodologies
Support the integration of risk controls into manufacturing processes, inspection plans and quality controls
Support Product and Engineering teams during design transfer, ensuring device design specifications can be translated into sustainable, controlled and high‑yield manufacturing processes
Identify manufacturing risks and quality requirements early in the product development lifecycle
Conduct or support Gage Repeatability & Reproducibility (Gage R&R;) studies to verify that measurement systems and operators provide accurate and reproducible results
Participate in CAPA teams and lead quality initiatives associated with product design, development and manufacturing readiness
Manage and complete assigned projects within the Quality and Regulatory Affairs function
Qual
📌 Quality Engineering Specialist (Winnipeg)
🏢 Myant
📍 Winnipeg