Quality Management System Specialist - Kitchener, Canada - Cloud DX, Inc.

Cloud DX, Inc.

Verified Company

Kitchener, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Company Description

About Cloud DX
Cloud DX is an industry leader in digital health care, virtual care, remote patient monitoring hardware and software.

The company's award-winning solutions enable chronically ill patients to stay at home and out of the hospital, drastically improving health outcomes while, at the same time, significantly reducing costs to treat the most expensive patients in the healthcare system.

Cloud DX is relentlessly committed to serving patients, driving Innovation, delivering results, and making a difference in communities across North America and globally.

The Company was founded in 2014 and has grown into a leader in the Virtual Care Market in North America.

The current COVID crisis has accelerated the adoption of virtual care in our markets and Cloud DX is investing in expanding our US Sales and Marketing efforts.

Job Description:

The Role

Responsible for ensuring that QMS processes and documentation is conformant to related standards required for regulatory compliance.
Administer and assist in the development of standards and workflows within our QMS as directed by your manager.

Major

Responsibilities:

Interfaces with R&D team to ensure that PDLC process and design principles fulfill all related regulatory requirements
Ensures that PDLC process and documents adhere to related standards
Performs gaps analysis between existing process and documentation processes and related standards
Assess compliance with standards and regulations and identify remedial action if necessary
Interface with Ethical Research Boards and participating academic of health institutions during studies and trials
Coordinate study meetings (I.e., investigator/study coordinator/advisory board/ sales)
Participate in internal development/commercial stud activities

Additional Information