Quality Systems Associate

Cambridge Design Partnership; Raleigh (NC); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Employee-owned

Job summary

Cambridge Design Partnership in Raleigh, NC, is seeking an early-career Quality Management System administrator to support our QMS and ISMS efforts across ISO standards. You will help maintain non-conformance, CAPA, change control, and document control systems within our eQMS.

The role emphasizes training, internal audits, and coordination of audits, with opportunities to learn across projects and improve processes while collaborating with cross-functional teams.

Qualifications

• Minimum 3 years in quality roles, ISO 9001/13485/27001 a plus.
• Experience in a Quality Assurance department.
• High School Diploma or GED.
• Experience with document control.
• Familiarity with internal audits and supplier controls.
• Experience with external audits desirable.
• Comfort with training staff on management system processes.

Responsibilities

• Monitor and maintain non-conformance, CAPA, change control, and customer complaints systems.
• Author updates to management system documentation.
• Administer internal audit system and raise findings in the eQMS.
• Coordinate audits and certifications, including calendars and room logistics.
• Maintain standards library and renewal process.
• Support Management System Lead and provide training on processes.
• Provide general admin support to management system tasks.

Skills

Attention to detail

Proactive

Communication skills

Organization

Problem solving

Team collaboration

Office software

Education

High School Diploma or GED

Tools

eQMS system

Microsoft Office

Document control

Job description

This is a great role for someone at the start of their career as part of a QMS team, with some experience of medical device development. As part of the Management System team you will support the company in compliance to CDP’s Quality and Information Security Management Systems (QMS and ISMS) by undertaking the following activities:

• Monitoring and maintenance of the:
  • Non-conformance system
  • Corrective Action Preventive Action system
  • Opportunities for Improvement system
  • Change Control system
  • Customer Complaints system
  • Supplier Control system
  • Document control for the management system and for Projects
• Authoring updates to management system documentation
• Administration of the Internal audit system, including scheduling, management of internal audit reports, and raising findings in the eQMS
• Perform Internal auditing team to ensure compliance with SOPs and quality standards
• Coordination of certification audits and client audits or evaluations of CDP as a supplier, including booking relevant calendars, organising rooms and people according to agendas, support during the audit and other activities as required
• Standards library maintenance, including checking and approving new requests, making purchases, and managing the renewal process
• Coordination and support for Management Review meetings, including booking relevant calendars, minute taking, tracking actions raised
• Liaise with different process owners to generate Quality monthly metrics against KPIs
• Administration of Information Security incidents
• Use of a Helpdesk ticketing system for daily tasks
• Become an expert in the eQMS package and provide administration support for the system, including validation when required
• Provide training to other members of staff in management system processes, including the induction of new starters
• Working within project teams as required to perform project activities and ensure compliance with relevant processes under the management system
• Support Compliance training requirements for the management system and the business
• Additional administrative support for the quality management system as required
• Provide support to the Management System Lead as required
• Provide support for general operations tasks to support the business as required

Requirements

Skills and Attributes

• Proactive and adaptable with good initiative
• High level of attention to detail with a methodical approach, able to identify errors and process inconsistencies
• Problem solver, able to take on additional responsibilities and actively seek new learning opportunities
• Excellent organisational skills, used to multi-tasking and able to prioritise and juggle new tasks as they arise
• Effective communication and interpersonal skills, with the ability to work collaboratively across teams
• A collaborative approach to working
• Strong problem-solving and root cause analysis skills
• Routine administration experience including; filing documentation, booking meetings, minute-taking
• Computer literate with intermediate-advanced Microsoft Office skills
• Able to become an expert in new software packages with minimal support

Experience and Education

• Minimum 3 years’ experience in quality roles, particularly in a ISO 9001, ISO 13485 or ISO 27001-certified company
• Experience as part of a Quality Assurance department
• High School Diploma or GED equivalent required
• Experience with document control required
• Experience with non-conformance and CAP, supplier control and internal audit preferred
• Previous experience in external audits desirable
• Use of an eQMS system preferred

Benefits

We’re an employee‑owned innovation partner with a growing US team in Raleigh, NC, part of the Research Triangle. We bring ideas to life-from insight to engineering to pilot manufacture—across consumer and healthcare.