Myant Looking for Design Quality Specialist at Mississauga, Ontario, Canada Full Time

The Quality Assurance and Regulatory team have an exciting opportunity for a Design Quality Specialist role to support Myant’s drive to medical product commercialization and beyond. The role will focus primarily on assuring quality documentation and processes in the Design, Development and Design Transfer phases of the Product Development life cycle. The ideal candidate will have experience working in Medical Device companies under MDSAP/ISO 13485 QMS and with electronic QMS (eQMS) systems. Alternatively, Health Technology Management (Clinical Engineering) roles and strong familiarity with a range of patient monitoring technologies and applications, along with QMS experience would also be an asset. Myant is in the process of advancing the commercialization of the Skiin garment devices and Software as a Medical Device Products so experience in New Product Introduction (Software in particular) is advantageous. The ideal candidate will demonstrate enthusiasm, results-orientation, and great team play to achieve success in the multidisciplinary roles of this position. The Design Quality Specialist will report into the VP and Quality Assurance and Regulatory Affairs.

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 initiatives related to the design and development phases.
• Manage and complete assigned projects within the Quality and Regulatory teams.
• Experience working with electronics QMS systems.
• 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.
• Experience in software development methodologies
• Internal or external auditing experience in MDSAP and/or ISO 13485
• Strong understanding of Quality Engineering Principles, Quality Improvement processes.
• Familiar with Digital Health technology (IoT, patient worn medical devices)
• Strong collaboration, organizational and project management skills.
• Certification in Quality Management, Medical Device Auditor, Quality Engineer are a plus.

What we offer at Myant:

• Free SKIIN Employee Kit
• Employee stock options
• Paid Sick Days and Personal Days
• Group Health Insurance Plan
• RRSP matching Plan
• Employee Referral Program
• Corporate Events
• Exposure working in one of the most innovative and forward-thinking start-ups that is passionate and dedicated towards the healthcare industry.

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