Quality Engineer; Medical Devices

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.

• Maintain and improve digital and paper-based elements of the Quality Management System
• Plan, conduct and report on internal audits
• Support external audit readiness, including evidence packs, responses and follow-up actions
• Support compliance with ISO 13485 and quality risk activities aligned with ISO 14971
• Apply knowledge of ISO 9001 and quality engineering principles within a regulated medical device environment
• Manage controlled updates to procedures, forms and quality records
• Support CAPA and continuous improvement activities arising from audits and quality findings
• Work collaboratively with stakeholders to establish consistent and effective quality practices

• Experience in Quality Engineering or Quality Compliance within the medical device sector
• Strong working knowledge of ISO 13485 and an understanding of ISO 14971
• Knowledge of ISO 9001, quality management systems and regulatory compliance
• Experience supporting internal and external audit cycles for medical device products
• Understanding of CAPA, document control, quality risk management and continuous improvement
• Confidence working in a regulated, evolving scale-up environment
• Clear communication skills and the ability to work effectively with stakeholders across the business
• Strong attention to detail with a structured and practical approach to quality assurance

• Hybrid working arrangement in Whiteley, Hampshire
• 27 days' holiday, plus bank holidays and an additional day per year
• 40-hour working week
• 5% pension match
• Share scheme
• Cycle to work scheme
• Dental scheme and company lunch on Thursdays

If 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.