Quality Assurance Associate

Overview

In this role you will support and improve the Quality Management System across multiple sites. You will work within the Quality Assurance team to uphold regulatory compliance and drive improvements in processes and documentation. You will manage internal and customer audits, plus certification body audits to ISO 9001 and ISO 13485, ensuring non-conformities are addressed. You will also oversee the document control function at the Wotton site and collaborate with cross-functional teams to sustain quality.

Responsibilities

• Gate keep the document control process and ensure timely training on new/updated processes
• Lead and participate in internal audits across manufacturing sites; assess processes and documentation for compliance
• Host customer audits and coordinate cross-functional information and findings
• Prepare for and participate in certification body audits; address non-conformities with relevant departments
• Monitor quality indicators and trends; report to senior leadership and identify training needs
• Communicate effectively with senior leadership and cross-functional teams to maintain quality standards

Key requirements

• Two years of experience in quality assurance or related field
• Working knowledge of Change Control, Document Control, and 8D corrective action methodology
• Understanding of life sciences/device quality documentation (QM, DHF, DMR, DHR, PMS, IFU, PSUR)
• Lead Auditor Certification (must be obtained)
• Internal Auditor experience preferred
• Ability to work onsite in Wotton, Surrey
• Proficiency with Windows and Microsoft Office (Teams, Excel, Visio) and related tools

• Strong teamwork and collaboration
• Effective communication and training abilities
• Ability to work independently and manage multiple projects
• ISO 9001 and ISO 13485 knowledge
• Document control and change control processes
• Internal and supplier/audience auditing

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