Quality Engineer

Quality Engineer

Up to £42k DOE

Monday - Thursday 07:00 - 16:00,Friday 07:00 - 13:00

Seeking 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.