QMS Coordinator - Medical Program

What you’ll do:

Collaborate with clients and other functions within Intertek to support clients’ medical certification activities.
Support certification programs including ISO 13485, MDSAP, ISO 9001, ANSI/NSF 455 and ISO 22716.
Coordinate efforts between client and Intertek Medical Notified Body as it pertains to MDR/EC certification activities.
Deal with client technical questions, document requests, billing issues, and complaints/disputes.
Process changes that affect medical device certifications (i.e., address, scope, employee count, and jurisdiction changes)
Work with program management, auditors, scheduling, sales, finance, and other functions to ensure consistent and compliant medical certifications.
Manage an external database to ensure timely reporting to regulatory agencies and manage a shared email inbox.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.

Minimum Requirements & Qualifications:

Bachelor's Degree
Strong analytical, organizational, communication and creative critical thinking skills
Technologically savvy and proficient with Microsoft Office suite
At least 2 years of experience with quality management systems
This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Preferred Requirements & Qualifications:

Work experience includes direct QMS responsibilities.
Experience working for a medical device, pharma, cosmetics, and/or dietary supplement company.
Experience working for a registrar/AO/Notified Body.