QMS Coordinator - Medical Program

Intertek

9d•Remote

About The Position

Intertek, a leading provider of quality and safety solutions, is actively seeking a Medical Program Coordinator to join our Business Assurance team remotely. This role offers a great opportunity to build a career in the medical device and third-party certification industries. The Business Assurance team focuses on enhancing client success through their operating procedures, systems, and people. Intertek is dedicated to reducing risk for consumers, brands, and organizations globally, going beyond traditional testing, inspection, and certification to provide Total Quality Assurance. Our purpose is to bring quality, safety, and sustainability to life. The Medical Program Coordinator will collaborate with clients and internal functions, including the Medical Notified Body, to support medical certification projects such as ISO 13485, MDSAP, and MDR.

Requirements

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
Must reside in and be able to legally work in the United States

Nice To Haves

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.

Responsibilities

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.