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.

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

Quality Management System & Regulatory Compliance

Support the development, implementation and continuous improvement of Quality Management System processes within a regulated medical device environment

Ensure quality engineering activities are conducted in accordance with applicable requirements, including:

ISO 13485

ISO 14971

MDSAP

EU MDR

FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820 requirements, as applicable

Work effectively within electronic Quality Management System (eQMS) platforms to manage quality records, investigations, CAPAs, documentation and other QMS activities

Author, review and approve technical and quality documentation as appropriate to the role

Participate as an Internal Auditor, supporting the ongoing assessment and improvement of QMS effectiveness

Support internal, supplier and regulatory audits and inspections

Support preparation for regulatory inspections and third‑party audits

Ensure assigned quality activities are completed in accordance with applicable procedures, timelines and regulatory requirements

CAPA, Non‑Conformance & Continuous Improvement

Participate in and lead investigations into product, process, material and supplier‑related non‑conformances

Apply structured root cause analysis methodologies to identify systemic causes rather than symptoms

Develop and implement effective corrective and preventive actions

Establish appropriate effectiveness checks to confirm that CAPA actions have addressed the underlying issue

Identify opportunities to strengthen processes, reduce recurring defects and improve overall manufacturing quality

Use quality data and trend analysis to proactively identify opportunities for improvement

Collaborate with cross‑functional teams to ensure corrective actions are implemented effectively and sustainably

Supplier Quality Management

Collaborate with Procurement, Manufacturing and Quality teams to evaluate and qualify new component, material and service suppliers

Assess supplier capabilities and quality systems as part of the supplier onboarding and qualification process

Support the development and implementation of supplier quality requirements and Quality Agreements

Conduct or support supplier quality audits, including remote and on‑site audits, to assess manufacturing processes, QMS effectiveness and applicable GMP requirements

Identify supplier process and quality risks and work with suppliers to establish appropriate controls

Issue and manage Supplier Corrective Action Requests (SCARs) for supplier‑related non‑conformances

Drive suppliers to complete appropriate root cause investigations and implement effective corrective and preventive actions

Verify the effectiveness of supplier corrective actions

Monitor supplier quality performance using appropriate metrics, including defect rates, quality‑related delivery performance, audit findings and corrective action status

Maintain and review Supplier Quality Scorecards and elevate significant supplier quality risks as required

Partner with Procurement and Operations to support supplier performance improvement and risk mitigation

Cross‑Functional Collaboration

Act as a quality engineering partner to Manufacturing, Operations, Engineering, Product, Procurement, Quality and Regulatory teams

Provide practical quality engineering guidance during product development, design transfer, manufacturing scale‑up and process changes

Participate in cross‑functional problem‑solving and continuous improvement initiatives

Communicate quality risks,



issues and recommendations clearly to both technical and non‑technical stakeholders

Promote a culture in which quality and regulatory compliance are embedded into day‑to‑day decision‑making rather than treated as separate activities

Contribute to Myant's collaborative, innovative and results‑oriented culture

Qualifications

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Life Sciences or a related technical discipline

Minimum 5 years of progressive Quality Engineering experience, preferably within the medical device industry

Hands‑on experience working within a medical device manufacturing setting

Working knowledge of ISO 13485, ISO 14971, FDA QMSR / 21 CFR Part 820 and EU MDR

Experience working within an MDSAP and/or ISO 13485 Quality Management System

Demonstrated experience developing, facilitating or contributing to Process FMEAs (pFMEAs), particularly for assembly and packaging processes

Experience with supplier quality management, supplier qualification and supplier auditing

Strong understanding of Quality Engineering principles, quality improvement methodologies and manufacturing process controls

Demonstrated experience with CAPA systems, and non‑conformance management and quality investigations

Experience supporting or conducting manufacturing validation activities, including process, equipment and/or software validation

Experience working with electronic Quality Management Systems (eQMS)

Experience supporting or participating in regulatory, notified body, certification or third‑party quality audits

Strong technical writing skills, with the ability to author, review and interpret quality and technical documentation

Strong analytical and problem‑solving skills with the ability to use quality and manufacturing data to identify trends and risks

Demonstrated ability to work effectively across multidisciplinary technical and operational teams

Strong communication and interpersonal skills

Ability to manage multiple projects, priorities and deadlines in a fast‑paced, evolving environment

Preferred Qualifications

Master's degree in engineering, Quality, Life Sciences or a related field

ISO 13485 or ISO 9001 Auditor certification

ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) or equivalent certification

Experience with MDSAP audit requirements

Experience working within organizations operating across multiple regulatory jurisdictions and markets

Experience supporting medical device commercialization across North American and European markets

Professional Engineer (P.Eng.) designation or eligibility

Certified Engineering Technologist (CET) designation or eligibility

Experience with supplier quality in a complex manufacturing or regulated product environment

Experience with electronic, electromechanical or wearable medical devices

KEY COMPETENCIES
Quality & Regulatory Expertise: Strong understanding of regulated medical device quality systems, manufacturing controls and applicable regulatory requirements.

Analytical & Problem Solving: Uses data, structured investigation methodologies and sound engineering judgment to identify root causes and develop effective solutions.

Risk-Based Thinking: Recognizes potential quality and manufacturing risks and proactively develops appropriate controls and mitigation strategies.

Technical Excellence: Demonstrates strong technical knowledge across quality engineering, process control, validation, measurement systems and manufacturing quality.

Collaboration: Works effectively across Quality, Regulatory, Engineering, Manufacturing, Operations, Product and Procurement teams.

Ownership & Accountability: Takes ownership of assigned investigations, projects and quality initiatives and follows through to effective completion.

Communication: Communicates complex quality and technical issues clearly and effectively through written documentation, presentations and cross‑functional discussions.

Continuous Improvement: Looks beyond individual quality issues to identify systemic opportunities to improve processes, reduce defects and strengthen the overall QMS.

Adaptability: Thrives in a fast‑paced, evolving technology and medical device environment where processes and products continue to scale and mature.

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📌 Quality Engineering Specialist (On SIte) (Ontario)
🏢 Myant
📍 Ontario