Quality Systems Associate

This is an early-career role for someone with 1–3 years’ experience in a quality management system, ideally in medical devices. You’ll join our small Management System team and help keep our Quality (QMS) and Information Security (ISMS) systems running day to day, for the US office and to cover the UK “out of hours”. You’ll get broad exposure to ISO 13485, ISO 9001 and ISO 27001 in a design and development setting.

Please note: this is not a GMP manufacturing or pharmaceutical QA role. Experience with an ISO-certified QMS is essential.

Job Duties and Responsibilities

Quality system processes: Maintain and monitor our nonconformance, CAPA, opportunities for improvement, change control, customer complaints and supplier control processes in our eQMS.

Document control: Manage document control for the management system and for client projects. Draft updates to procedures and work instructions.

eQMS administration: Become our in-house expert on the eQMS, including supporting system validation when needed.

Internal audits: Schedule internal audits, take part as an auditor, manage audit reports and log findings in the eQMS.

External audits: Coordinate certification audits and client audits of CDP as a supplier, including scheduling, logistics and support on the day.

Management review and metrics: Help prepare management review meetings, take minutes and track actions. Work with process owners to produce monthly quality metrics against KPIs.

Training: Deliver management system training, including onboarding for new hires, and support compliance training across the business.

Information security: Log and administer information security incidents.

Standards library: Review and approve requests, make purchases and manage renewals.

Project support: Work with project teams to make sure project activities follow our QMS processes. Handle day-to-day requests through our helpdesk ticketing system and provide general operations support as needed.

Business Support Needs: Provide support to the Quality Manager for QMS projects as needed and general operations tasks to support the business as required

Requirements

• Associate’s or bachelor’s degree, or equivalent work experience
• 1–3 years’ experience in a quality role within an ISO 13485, ISO 9001 or ISO 27001-certified organization
• Hands-on document control experience
• Experience with CAPA, nonconformance, supplier control or internal audits
• Exposure to external certification or client audits
• Basic root cause analysis skills
• Strong attention to detail and a methodical approach, with the ability to spot errors and process inconsistencies
• Excellent organizational skills and the ability to prioritize competing tasks
• Clear communication skills and a collaborative way of working
• Intermediate to advanced Microsoft Office skills
• Routine administration experience
• Preferred: Medical device QMS experience (ISO 13485 and/or FDA QMSR / 21 CFR 820)
• Experience using an eQMS and supporting the implementation of a new system