Quality Engineer (Medical Devices)

NegotiableFareham, England Permanent Our client, an innovative medical device business based near Fareham in Hampshire, is seeking a Quality Engineer to support the development and continuous improvement of its Quality Management System.

Working within a growing medical technology environment. This permanent, hybrid position is focused on quality systems, compliance and auditing. The successful applicant will help maintain audit readiness, support regulatory compliance and embed practical quality processes across the business.

Key Responsibilities

Maintain and improve digital and paper-based elements of the Quality Management SystemPlan, conduct and report on internal auditsSupport external audit readiness, including evidence packs, responses and follow-up actionsSupport compliance with ISO 13485 and quality risk activities aligned with ISO 14971Apply knowledge of ISO 9001 and quality engineering principles within a regulated medical device environmentManage controlled updates to procedures, forms and quality recordsSupport CAPA and continuous improvement activities arising from audits and quality findingsWork collaboratively with stakeholders to establish consistent and effective quality practicesJob

Requirements

Experience in Quality Engineering or Quality Compliance within the medical device sectorStrong working knowledge of ISO 13485 and an understanding of ISO 14971Knowledge of ISO 9001, quality management systems and regulatory complianceExperience supporting internal and external audit cycles for medical device productsUnderstanding of CAPA, document control, quality risk management and continuous improvementConfidence working in a regulated, evolving scale-up environmentClear communication skills and the ability to work effectively with stakeholders across the businessStrong attention to detail with a structured and practical approach to quality assuranceBenefits: Hybrid working arrangement in Whiteley, Hampshire27 days' holiday, plus bank holidays and an additional day per year40-hour working week5% pension matchShare schemeCycle to work schemeDental scheme and company lunch on ThursdaysIf you are an experienced Quality Engineer with medical device, quality systems and audit experience, this is an excellent opportunity to support the growth of an innovative healthcare technology business. Apply now to take the next step in your career.

Report this job