What we do

At Myant, we are creating the world’s first expressive and continuous digital presence platform, enabled by integrating technology directly into clothing and augmented by other devices, wearables, and IOT. We see the evolution of society where every member gets to participate from anywhere and anytime through a whole-body experience, mostly in a passive or ambient manner to foster ubiquitous accessibility. Humans have a fundamental desire and need to be connected to our environment, family, community, and technology. This level of connection will create a paradigm shift in the way we deal with each other, especially from afar, allowing for more meaningful relationships, and more in-depth representation of ourselves.

The need for this type of connection is not new. There are many companies working on ways to connect humans in singularity with technology, however most of these technologies are based on devices that are often used in episodical ways hence, leading to poor adoption or reliability. In general, innovation and technology have delivered significant benefits for many members of society. However, there are those who are left behind, namely the very young, the marginalized, the old and the sick. The challenge of inclusion for those left behind requires us to move beyond device focused strategies, towards an interface that we use naturally, every day. We believe that textile is that primary interface, used in clothing, coverings, carpeting and more, we wear and are surrounded by textiles universally, always.

Such an interface could fuse data with other devices that we use periodically and data with other IoTs in the environment. People could then leverage their physical presence over their digital presence to communicate and share personal wellbeing. This could unlock healthcare that is proactive and preventative, social connectedness that is more profound, enable care distribution models to be seamless and on demand, better fitness insights, safer working environments and more.

The vision for SKIIN -our first consumer-facing brand- is to enhance human ability through connected clothing and textiles. Skiin is in beta-phase market launch and has been recently granted Health Canada medical device license and submitted to FDA for regulatory approval in the US market. The sensors and actuators embedded within our apparel create your Digital Identity, which will be consumed by those who matter to you - your family members, physicians, trainers, other IoT devices - without you consciously having to think about it. The line between the digital and physical world is becoming increasingly blurry and we believe textile is the next medium to bridge that gap.

We are a multi-disciplinary technology team solving big challenges at the intersection of electronics, deep tech., software, design, advanced manufacturing, and data science.

What we offer at Myant:

Employee stock options

Paid Sick Days and Floating Days

Group Health Insurance Plan

RRSP matching Plan

Corporate Events

Exposure working in one of the most innovative and forward-thinking tech companies.

Myant is a diversified, equal opportunity employer. People with a disability or a special accommodation request may send an email to [email protected].

Senior Quality Assurance Specialist

Etobicoke, ON, Canada

Full Time

Experienced

Role Overview:

Myant is a leading innovator in the field of textile-based technology, leveraging advanced materials and smart fabrics to enhance human health and wellness. With our cutting-edge developments in wearables, we aim to revolutionize how the world approaches personal care and health monitoring. We are looking for a passionate HR Manager to join our team and contribute to building a dynamic, collaborative, and innovative workplace culture.

The Senior Quality Assurance Specialist is a senior individual contributor responsible for strengthening and scaling Myant’s Quality Management System (QMS) within a regulated medical device environment, including Software as a Medical Device (SaMD) and software-enabled products.

This role provides systems-level quality leadership, ensuring compliance with global regulatory standards (ISO 13485, MDSAP, EU MDR, and FDA QMSR), while driving risk-based decision-making, design control governance, and validation oversight. Acting as a key partner across Engineering, Operations, Regulatory Affairs, and Manufacturing, this role ensures quality and compliance are embedded across the full product lifecycle as the organization expands across North American and European markets.

Key Responsibilities:

Quality Management System (QMS) & Compliance

Drive and maintain alignment of the QMS with ISO 13485, MDSAP, EU MDR, and FDA QMSR (21 CFR Part 820) requirements across multiple sites
Monitor evolving regulatory requirements and lead gap assessments and implementation activities to maintain inspection readiness
Exercise final quality review and approval authority for quality system documents, validations, investigations, and controlled records

Risk Management

Lead risk management activities in accordance with ISO 14971, including risk planning, hazard analysis, risk evaluation, control implementation, and residual risk assessment
Ensure integration of risk outputs with complaints, CAPA, post-market surveillance, and design changes

Design Control & Product Lifecycle Quality

Own and govern design control processes for medical devices and SaMD products
Lead design planning, design input/output definition, design reviews, verification and validation oversight, and design transfer
Ensure completeness, traceability, and integrity of DHFs, DMRs, and DHRs

Validation Governance

Own enterprise validation strategy and governance, including process validation, software validation, equipment qualification, and product validation
Ensure validation planning, protocol development, review, approval, and execution meet regulatory and quality requirements

CAPA & Nonconformance Management

Own the CAPA system, ensuring robust investigation practices, root cause analysis, implementation, effectiveness verification, and escalation of systemic issues
Provide oversight of nonconforming product (NCR) processes, including investigation, disposition, trending, and linkage to CAPA

Change Control

Own quality decision-making within change control (ECR/ECN), including risk and validation impact assessments and final approvals
Ensure all changes maintain compliance across design, process, and documentation

Supplier Quality & External Partners

Provide quality oversight for supplier qualification, approval, monitoring, and re-evaluation in partnership with the QMS Administrator
Support development and maintenance of quality agreements with suppliers, contract manufacturers, and service providers

Audit & Inspection Readiness

Own internal audit program strategy, including planning, scope, interpretation of findings, and follow-up on corrective actions
Support external audits including notified bodies, customers, FDA inspections, and MDSAP audits
Lead preparation, response coordination, and closure of audit observations

Quality Operations & Oversight

Provide systems-level oversight of production and process quality controls
Own governance of the calibration program, ensuring compliance while execution is performed by QA Inspector
Oversee management review inputs including KPIs, quality metrics, and trend analysis

Post-Market & Cross-Functional Collaboration

Partner with Regulatory Affairs on complaint trends, post-market surveillance, and reportability assessments
Ensure integration of post-market data into CAPA, risk management, and design control processes
Collaborate cross-functionally with Engineering, Software, Operations, V&V, Program Management, and Manufacturing

Leadership & Continuous Improvement

Mentor QA Inspector and cross-functional teams on quality systems, risk-based thinking, and investigation rigor
Drive continuous improvement initiatives across quality processes, focusing on scalability, standardization, and efficiency

Required Qualifications

Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Software, or related), Life Sciences, or a related technical field
Minimum 7 years of progressive quality assurance experience in the medical device industry, including 3+ years in a senior or lead role
Strong working knowledge of ISO 13485, ISO 14971, FDA QMSR (21 CFR Part 820), and EU MDR
Experience with MDSAP audit requirements and multi-market regulatory environments
Proven experience leading design control activities for medical devices and/or SaMD
Strong experience with CAPA systems, root cause analysis, and effectiveness verification
Experience with validation governance (process, software, equipment)
Demonstrated experience supporting or leading regulatory inspections and audits
Strong communication skills with the ability to author and review technical and regulatory documentation
Proven ability to collaborate cross-functionally across technical and operational teams

Preferred Qualifications

Master’s degree in Engineering, Quality, Regulatory Science, or related field
ASQ certifications (CQE, CQA) or equivalent
ISO 13485 or MDSAP Lead Auditor certification
Experience with Software as a Medical Device (SaMD) and IEC 62304
Experience supporting 510(k) submissions from a quality/design control perspective
Familiarity with IEC 62366 (usability) and IEC 60601 (electrical safety)
Experience in multi-site or scaling quality systems
Familiarity with eQMS platforms (e.g., Greenlight Guru, MasterControl, Veeva, ETQ)
Experience with post-market surveillance and field data integration into QMS processes

Join us, and help build a healthier, more connected future.

Apply for this position

Required*

First Name*

Last Name*

Email Address*

Phone*

Address

Resume*

We've received your resume. Click here to update it.

Attach resume or Paste resume

Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

Human Check*

Submit Application