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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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 escalate significant supplier quality risks as required.
- Partner with Procurement and Operations to support supplier performance improvement and risk mitigation.
6. 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.