QMS Coordinator - Medical Program
About The Position
Intertek, a leading provider of quality and safety solutions, is seeking a Temporary Medical Program Coordinator to join their Business Assurance team remotely. This role offers an 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 innovation and risk reduction for consumers, brands, and organizations globally, functioning as a Total Quality Assurance Provider. Their purpose is to bring quality, safety, and sustainability to life.
Requirements
- High School Diploma or GED
- 2+ years of administrative experience
- Technologically savvy and proficient with Microsoft Office suite
- Strong problem-solving skills
- Strong interpersonal skills
- Strong communication skills in both verbal and written formats
- Strong organization, time management, and prioritization skills
- Ability to work independently in a fast-paced, multi-tasking environment with shifting priorities
- Strong analytical, organizational, communication, and creative critical thinking skills
- Must reside in and be able to legally work in the United States
Nice To Haves
- Direct QMS responsibilities experience
- 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 internal functions, including the Medical Notified Body, to support medical certification projects (ISO 13485/MDSAP/MDR).
- Support certification programs such as ISO 13485, MDSAP, and ISO 9001.
- Coordinate between clients and Intertek Medical Notified Body for MDR/EC certification activities.
- Address client technical questions, document requests, billing issues, and complaints/disputes.
- Process changes affecting medical device certifications (e.g., address, scope, employee count, jurisdiction).
- Liaise with program management, auditors, scheduling, sales, finance, and other departments to ensure consistent and compliant medical certifications.
- Manage an external database for timely reporting to regulatory agencies.
- Manage a shared email inbox.
Benefits
- Opportunity to grow a versatile career in the medical device and third-party certification industries.
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What This Job Offers
Career Level
Entry Level
Education Level
High school or GED
