Hays
Quality Assurance & Regulatory Affairs Engineer
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Your new company An established and growing organisation operating within the Medical Device and Healthcare sector. With a strong commitment to quality, compliance and innovation, the business develops and manufactures products that have a direct impact on patient outcomes. As the organisation continues to expand its manufacturing capabilities and product portfolio, it is seeking an experienced quality professional to support both operational excellence and regulatory compliance.
Your new role As the Quality Assurance & Regulatory Affairs Engineer, you will play a key role in supporting manufacturing operations, quality systems and product life cycle activities. Working closely with Quality, Operations, Manufacturing, Product Development and Supply Chain teams, you will lead investigations, CAPAs, non-conformances, complaint handling and root cause analysis activities. You will also support change controls, supplier quality, risk management, validation activities and continuous improvement initiatives, while contributing to technical documentation and regulatory compliance activities. This is a hands-on role that requires regular engagement with manufacturing teams to identify issues at source and implement practical, effective solutions.
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What you'll need to succeed To be successful in this role, you will ideally have:
- Experience within Medical Devices, Diagnostics or another highly regulated manufacturing environment.
- Strong knowledge of ISO 13485 and Quality Management Systems.
- Experience managing CAPAs, non-conformances, complaints and root cause investigations.
- Knowledge of quality tools such as 8D, 5 Why, Fishbone and FMEA.
- Experience supporting manufacturing quality and process improvement initiatives.
- Exposure to supplier quality, change control and risk management activities.
- Strong documentation and problem-solving skills.
- Experience with Technical Documentation, ISO 14971, UK MDR, EU MDR, Design Controls or validation activities would be advantageous.
- Excellent stakeholder management and communication skills.
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Please note: sponsorship is not available for this role. Applicants must have the right to work in the UK at the time of application.
What you'll get in return The opportunity to join a growing and innovative organisation within the Medical Device sector. A varied role with exposure across Quality Assurance, Regulatory Affairs, Manufacturing and Product Development. The chance to influence quality improvements across the business. A collaborative environment with direct access to senior stakeholders. Ongoing professional development and career progression opportunities. Competitive salary and benefits package.
What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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