Job Description
Quality Engineer Up to £42k DOEMonday - Thursday 08:00 - 17:00,Friday 08:00 - 14:00Seeking a Quality Engineer to work closely with Operations, Manufacturing, R&D, and Quality teams to drive continuous improvement and ensure compliance with industry standards. The role involves managing quality processes, investigating non-conformances, and implementing corrective and preventive actions (CAPA).Key Responsibilities:Lead quality investigations for market defects, identifying root causes and implementing CAPA.Collaborate with cross-functional teams on failure modes and impact assessments.Interface with customers and suppliers to address manufacturing non-conformances.Drive process improvement initiatives using SPC, Six Sigma, and Lean methodologies.Ensure manufacturing processes meet operational and regulatory requirements (ISO 9001, 13485, 21 CFR Parts 210 & 211).Support audits, change control, document control, and product validation.Provide training and guidance on best practices and quality standards.Requirements:Degree in Business, Sciences, or Engineering.5+ years’ experience in quality operations within biotech or pharmaceutical manufacturing.Strong knowledge of ISO 9001/13485 and regulatory compliance.Proficiency in problem-solving tools (ASQ, Green Belt, Lean Six Sigma preferred).Excellent communication, collaboration, and decision-making skills.Advanced MS Office skills preferred.