Quality Engineering Specialist (On Site)

About MyantAt 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 OverviewMyant 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 environment
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 COMPETENCIESQuality & 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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