Design Quality Specialist - Mississauga, Canada - Myant

Myant

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

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 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 1348
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 forwardthinking startups that is passionate and dedicated towards the healthcare industry.