We are seeking an experienced Quality Engineer, to join our Quality Team, to support and enhance our manufacturing operations through strong ownership of quality systems and regulatory compliance. This is a systems-focused role that is critical to maintaining ISO and other regulatory certifications, ensuring robust internal process qualification, and driving continuous improvement across production processes. The role involves regular interaction with auditors, regulatory bodies, and customers during on-site visits and audits. Key Responsibilities: Own, maintain, and continuously improve the ISO Quality Management System (QMS). Ensure compliance with all internal, customer, regulatory, and product certification requirements, including process qualification and internal controls. Develop, review, update, and control QMS documentation, including procedures, SOPs, work instructions, control plans, and quality records. Maintain effective document and system control, ensuring audit readiness at all times. Plan, coordinate, support, and host internal, external, regulatory, and customer audits. Act as the primary point of contact for auditors, regulatory bodies, and customers during on-site audits and visits. Monitor, analyse, and report quality KPIs, including scrap, rework, yield, and customer complaints. Support production teams with process improvement, standardisation, and day-to-day quality issue resolution. Promote a culture of compliance, quality discipline, and continuous improvement across manufacturing operations. Qualifications and Experience: Degree or equivalent qualification in Mechanical Engineering or other associated discipline. Experience in a Quality Systems role with hands-on experience managing ISO-based Quality Management Systems, including dealing directly with auditors, regulatory bodies, and customers during on-site audits. A strong understanding of process qualifications, internal compliance, and system governance. Experience leading quality system improvement or remediation initiatives Strong attention to detail, organisational skills, and the ability to manage complex documentation. Familiarity with Lean, Six Sigma, or continuous improvement methodologies. Lead Auditor or Internal Auditor certification would be an advantage. Benefits: Gym private healthcare uniform enhanced pension reward & recognition scheme