Principal Quality Associate

Principal Quality AssociateCheck you match the skill requirements for this role, as well as associated experience, then apply with your CV below. Bicester (On-site) Medical Devices | Quality & ComplianceWere looking for an experienced Principal Quality Associate to join our Quality team at our Bicester site, playing a key role in maintaining and strengthening quality and compliance across the business.Reporting to the Compliance Director, youll work closely with Quality Control, Manufacturing and Suppliers to ensure products meet regulatory and customer requirements from incoming inspection through to goods release, audits, and corrective actions.This is a hands-on, influential role for someone who thrives in a regulated environment and enjoys turning quality requirements into practical, compliant processes.What Youll Be Responsible ForSupporting incoming inspection and goods release activities in collaboration with the Quality Control teamInvestigating product non-conformities and driving effective corrective and preventive actions (CAPA)Developing, implementing and maintaining compliant quality processes aligned to regulatory standardsPlanning, conducting and completing internal audits and supplier auditsSupporting external audits, including preparation of documentation and participation during assessmentsLogging, investigating and documenting non-conformities (NCs) and CAPAs, ensuring timely resolutionMonitoring and maintaining goods-in quality metrics, preparing data for quality and management reviewsConducting supplier evaluations and supporting supplier compliance meetings with relevant data and insightsCoordinating Quality Control tasks to ensure product holds are resolved efficiently and compliantlySupporting quality activities at GBUK acquisition sitesUndertaking additional quality-related tasks as required by the Head of Quality or Compliance DirectorWhat Were Looking ForEssentialExperience working in a Quality role within the Medical Device industryStrong working knowledge of a recognised QMS (ISO 13485 or ISO 9001 as a minimum)Experience conducting internal audits (Lead Auditor level desirable)Hands-on experience with CAPA, non-conformities and root cause analysisExperience writing and implementing processes compliant with standardsExcellent attention to detail with a structured, methodical approachStrong communication skills and the ability to work effectively across teamsA proactive, problem-solving mindset with the ability to manage multiple prioritiesDesirableKnowledge and experience of MDRExperience or knowledge of FDA incident reportingSupplier audit experienceWhy Join Us?A senior, influential quality role with real impactClose collaboration with manufacturing, suppliers and leadershipA business that values practical quality, not just paperworkOpportunity to support quality across a growing organisationImportant Candidates must be based in or able to commute to the Bicester area. xjdpvnf This is an on-site role.

Created: 2026-01-16