Quality Engineer (Medical Devices)

Overview

In this role you will support the development and continuous improvement of the Quality Management System within a growing medical technology environment. You will work to maintain audit readiness and ensure regulatory compliance across the business. You’ll embed practical quality processes and collaborate with stakeholders to establish consistent practices. This hybrid position offers impact through quality improvements that enable scalable, compliant medical device operations. You will contribute to a mission-driven team focused on high-quality healthcare solutions.

Pay / Benefits

• Hybrid working
• 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

Responsibilities

• 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

Key requirements

• 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

• Clear communication
• Stakeholder collaboration
• Attention to detail
• ISO 13485
• ISO 14971
• ISO 9001

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