Quality Assurance Officer

About this role

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.