Quality Assurance Associate, ISO & eQMS

Cambridge Design Partnership; Raleigh (NC); On-site; USD 60,000 - 82,000; Full time

Job summary

Cambridge Design Partnership in Raleigh, NC is seeking an early-career professional to support our Quality Management System (QMS) and Information Security Management System (ISMS). You will assist with non-conformance, CAPA, change control, and supplier controls while helping maintain documentation and participate in audits.

The role emphasizes training, cross-team collaboration, and ongoing learning in medical device development compliance.

Qualifications

• Minimum 3 years' experience in quality roles in ISO 9001/13485/27001 environments.
• Experience in a Quality Assurance department within a regulated setting.
• Experience with document control and internal audits.
• Familiarity with corrective actions, non-conformances and supplier controls.

Responsibilities

• Monitor and maintain the non-conformance, CAPA, and change control systems.
• Administer document control for the management system and projects.
• Coordinate internal audits and assist with external audits or evaluations.
• Maintain the standards library and support management reviews.
• Provide training on management system processes and SOPs.

Skills

Proactive, adaptable

Attention to detail

Problem solving

Organization

Communication

Team collaboration

Root cause analysis

Administration

Education

High School Diploma or GED

Tools

eQMS

MS Office

Job description

Cambridge Design Partnership in Raleigh, NC is seeking an early-career professional to support our Quality Management System (QMS) and Information Security Management System (ISMS). You will assist with non-conformance, CAPA, change control, and supplier controls while helping maintain documentation and participate in audits.

The role emphasizes training, cross-team collaboration, and ongoing learning in medical device development compliance.