Design Quality Specialist - Mississauga, Canada - Myant
Description
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.
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