QMS Coordinator - Medical Program

Medical Program Coordinator - Remote

Intertek, a leading provider of quality and safety solutions to many of the world's top-recognized brands and companies, is actively seeking a Medical Program Coordinator to join our Business Assurance team remotely.

This is a fantastic opportunity to grow a versatile career in the medical device and third-party certification industries.

Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful.

Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace.

Intertek is continually innovating and evolving to reduce risk for consumers, brands and organizations in every sector and industry around the world.

We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide.

Our Purpose: Bringing quality, safety, and sustainability to life.

What are we looking for?

The Medical Program Coordinatoris responsible for collaborating with our clients and other functions, including our Medical Notified Body, to support their medical certification (ISO 13485/MDSAP/MDR) projects.

Salary & Benefits Information

In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.

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...