QMS Coordinator - Medical Program
Intertek · United States · 2 wk ago
RemoteRemoteOTHRFull-time
About the role
Intertek is seeking a Temporary Medical Program Coordinator to join our Business Assurance team remotely. This position supports medical certification projects (ISO 13485, MDSAP, MDR) by collaborating with clients and internal teams, including our Medical Notified Body.
Responsibilities
- Collaborate with clients and internal functions to support medical certification activities.
- Support certification programs including ISO 13485, MDSAP, and ISO 9001.
- Coordinate efforts between clients and Intertek’s 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 changes).
- Work with program management, auditors, scheduling, sales, finance, and other functions to ensure compliant certifications.
- Manage an external database for timely regulatory reporting and oversee a shared email inbox.
Requirements
- High School Diploma or GED.
- 2+ years of administrative experience.
- Proficiency with Microsoft Office suite.
- Strong problem-solving, interpersonal, and communication skills (verbal and written).
- Excellent organization, time management, and prioritization skills.
- Ability to work independently in a fast-paced, multi-tasking environment with shifting priorities.
- Must reside in and be legally eligible to work in the United States.
Preferred Qualifications
- Direct experience with Quality Management Systems (QMS).
- Experience in medical device, pharma, cosmetics, or dietary supplement industries.
- Experience working for a registrar, Authorized Organization (AO), or Notified Body.
About Us
Intertek is a leading Total Quality Assurance provider, delivering innovative Assurance, Testing, Inspection, and Certification (ATIC) solutions across industries worldwide. Our Business Assurance team provides management systems certification, sustainability audits, risk management, and training to help clients improve operations and workforce competencies.