Design Quality Specialist

7 days ago


Etobicoke, Canada Myant Full time

**About Us**:
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 têxtile is that primary interface, used in clothing, coverings, carpeting and more, we wear and are surrounded by têxtiles universally, at all times.

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 têxtiles. 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 têxtile is the next medium to bridge that gap.

We are a multi-disciplinary technology team solving big challenges at the intersection of fashion, electronics, software, and data science.

**The Role**:
**Responsibilities**:

- Ensure the conformance and compliance of the Design History Files (DHF) and associated documents to meet MDSAP/ ISO 13485:2016 and Jurisdictional Regulatory Requirements (e.g. HC, FDA)
- Assist in the preparation of documents in the development, design, and design transfer stages of the product realization processes with the Engineering, Data Science and Software teams.
- Conversion of Software development platform (Agile) outputs to DHF documentation.
- Contribute to the Technical Writing of Myant product documentation including, but not limited to, Regulatory Labels (Instructions for Use, Manuals), Regulatory documentation (e.g. dossiers, reports, standards compliance)
- Assist in 3rd party testing plans and reporting
- Create and revise QMS templates, SOPs, forms, and documents
- Participate in the CAPA team and lead improvement initiatives related to the design and development phases.
- Manage and complete assigned projects within the Quality and Regulatory teams.
- Participate in Internal Audits

**Qualifications**:

- Educational background: Degree in Engineering (Biomedical preferred) or Applied Sciences, or equivalent experience and knowledge.
- Experience in Quality Assurance and/or Quality Engineering roles in a MDSAP/ISO 13485 certified QMS.
- Familiar with medical device standards e.g. IEC 60601, IEC 62304, and design and development processes
- Familiar with product Risk Management as per ISO 14971.
- Strong understanding of Quality Engineering Principles, Quality Improvement processes.
- Familiar with Digital Health technology (IoT, patient worn medical devices)
- Internal or external auditing experience in MDSAP and/or ISO 13485 are a plus.
- Certification in Quality Management, Medical Device Auditor, Quality Engineer are a plus.
- Strong collaboration, organizational and project management skills.

**What we offer at Myant**:

- Free SKIIN Employee Kit
- Hybrid Work Model
- Employee stock options
- Paid Sick Days and Personal Days
- Group Health Insurance Plan
- Employee Referral Program
- Corporate Events
- Exposure working in one of t


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