We are seeking a Senior Quality Engineer to support manufacturing operations, drive quality and compliance initiatives, and ensure products and processes consistently meet regulatory and customer requirements. Working closely with Engineering and Operations teams, you will lead validation activities, support audits, manage quality investigations, and contribute to continuous improvement across products, processes, and quality systems.

Responsibilities

• Provide quality support and guidance to manufacturing and engineering teams, ensuring compliance with quality and regulatory standards.
• Lead validation activities for processes, equipment, software, and facilities, including associated documentation and risk assessments.
• Partner with Engineering on process improvements, product line extensions, work instruction updates, and FMEA activities.
• Manage non-conformance investigations, CAPAs, and root cause analysis to drive effective corrective and preventive actions.
• Support change control activities and assess the quality and validation impact of proposed changes.
• Analyse quality and manufacturing data to identify trends, improve performance, and reduce risk.
• Develop validation strategies, protocols, and sampling plans for new and existing manufacturing processes.
• Act as a key quality representative within cross-functional meetings, providing technical guidance and support where required.
• Conduct internal audits and support customer, regulatory, and certification audits.
• Ensure compliance across manufacturing, packaging, labelling, and GMP-related activities.
• Support the development of quality metrics and contribute to site-wide compliance and continuous improvement initiatives.
• Promote quality best practices while ensuring adherence to health, safety, environmental, and training requirements.

Skills & Experience

• Degree in Engineering, Science, or a related discipline.
• 5+ years’ experience within a regulated manufacturing environment, ideally within medical devices or a similar industry.
• Strong understanding of quality systems, validation, risk management, and regulatory compliance.
• Experience with CAPA, non-conformance investigations, root cause analysis, and continuous improvement activities.
• Familiarity with FMEA, statistical analysis, and quality improvement tools.
• Strong analytical, problem-solving, and communication skills.
• Proficient in Microsoft Office applications, particularly Excel, Word, and PowerPoint.
• Experience supporting internal and external audits is highly desirable.