Quality Assurance Officer

About the 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.

Responsibilities

• 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
• 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
• Provide support to the Management System Lead as required
• Provide support for general operations tasks to support the business as required

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 prioritize 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

Requirements

• 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.