QMS Implementation Consultant
QMS Implementation Consultant
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Job Description
Role: QMS Implementation Consultant
location: Remote
SKILLS:
Experience in managing the selection of QMS systems and overseeing RFQ processes.
Deep knowledge of medical device regulations (FDA ISO 13485 etc.) and quality management best practices.
Drive the vendor and solution selection of a new Quality Management System (QMS) for our manufacturing sites in the US and Europe.
Manage the Request for Proposal (RFP) process ensuring clear communication of requirements comprehensive evaluation of proposals and selection of optimal vendors and technology solutions.
Collaborate with key stakeholders across various departments including Quality IT R&D and Operations to gather input and align the QMS project objectives with each departments needs and workflows.
Work closely with the QMS implementation partner to ensure the project is executed according to the agreed plan timeline and budget.
Design and deliver training programs for endusers ensuring they are wellprepared to use the new QMS effectively.
Ensure that all aspects of the QMS implementation comply with relevant regulatory standards for medical devices including FDA regulations and ISO standards.
Experience with implementations of QMS in medical device industry companies (small/medium size).
Employment Type
Full Time
