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Design Quality Specialist
Location:
Mississauga
Description:
The Role: 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 (e QMS) 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 3 rd party testing plans and reporting Create and revise QMS templates, SOPs,. Visit ListedBuy for more information.
Company:
Myant
Posted:
May 23 on ListedBuy
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Design Quality Specialist is a Other Art & Media Jobs Quality Specialist Job at Myant located in United States. Find other listings like Design Quality Specialist by searching Oodle for Other Art & Media Jobs Quality Specialist Jobs.
Design Quality Specialist is a Other Art & Media Jobs Quality Specialist Job at Myant located in United States. Find other listings like Design Quality Specialist by searching Oodle for Other Art & Media Jobs Quality Specialist Jobs.