Remote Medical QMS & Certification Coordinator

Intertek CEA; Boxborough, Northern (MA, KY); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Remote work

401(k) with company match

Tuition reimbursement

Job summary

Intertek, a global leader in quality and safety, is seeking a Remote Medical Program Coordinator to support ISO 13485/MDSAP/MDR projects with clients and the Intertek Notified Body.

You will coordinate with internal teams and clients, manage documentation, and ensure compliance across certifications. The role requires strong analytical skills and experience with QMS systems, with remote work within the United States.

Qualifications

• Bachelor's degree required.
• 2+ years of experience with quality management systems.
• Strong analytical, organizational, communication and creative critical thinking skills.
• Remote work in the United States is allowed.

Responsibilities

• Collaborate with clients and Intertek teams to support medical certification activities.
• Support certification programs including ISO 13485, MDSAP, ISO 9001, ANSI/NSF 455 and ISO 22716.
• Coordinate with client and Intertek Medical Notified Body for MDR/EC activities.
• Address client questions, document requests, billing issues and disputes.
• Process changes affecting medical device certifications (address, scope, employee count, jurisdiction).
• Work with program management, auditors, scheduling, sales, finance and other functions to ensure compliant certifications.
• Manage an external database to ensure timely reporting to regulatory agencies and maintain shared email inbox.

Skills

Analytical skills

Organizational skills

Communication skills

MS Office

Quality Management Systems

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Intertek, a global leader in quality and safety, is seeking a Remote Medical Program Coordinator to support ISO 13485/MDSAP/MDR projects with clients and the Intertek Notified Body.

You will coordinate with internal teams and clients, manage documentation, and ensure compliance across certifications. The role requires strong analytical skills and experience with QMS systems, with remote work within the United States.