QA & QMS Coordinator — Medical Devices

Cambridge Design Partnership; Raleigh (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Cambridge Design Partnership in Raleigh, NC is seeking a Quality Management System Administrator at an early-career level to support CDP’s QMS and ISMS compliance. You will handle non-conformance, CAPA, change control, and document control while assisting with internal and supplier audits.

The role requires a minimum of 3 years in quality roles within ISO-certified environments, plus experience with eQMS and MS Office.

Qualifications

• Minimum 3 years’ experience in quality roles in ISO-certified environment.
• Experience in Quality Assurance department.
• High School Diploma or GED.
• Experience with document control.
• Experience with non-conformance, CAPA, supplier control, and internal audits preferred.
• Experience with external audits desirable.
• Use of an eQMS system preferred.

Responsibilities

• Monitor and maintain the Non-conformance, CAPA, and change control systems.
• Administer internal audits and manage audit reports.
• Coordinate certification audits and client evaluations of CDP as a supplier.
• Maintain standards library and renewal process.
• Generate Quality monthly metrics with process owners and track KPIs.
• Provide training on management system processes and induct new staff.
• Support the Management System Lead and general operations tasks as needed.

Skills

Attention to detail

Proactive mindset

Communication skills

Organizational skills

Problem solving

Collaboration

Education

High School Diploma or GED

Tools

eQMS

Microsoft Office

Job description

Cambridge Design Partnership in Raleigh, NC is seeking a Quality Management System Administrator at an early-career level to support CDP’s QMS and ISMS compliance. You will handle non-conformance, CAPA, change control, and document control while assisting with internal and supplier audits.

The role requires a minimum of 3 years in quality roles within ISO-certified environments, plus experience with eQMS and MS Office.