Quality Engineer

Quality Engineer

Up to £42k DOE

Monday - Thursday 08:00 - 17:00,Friday 08:00 - 14:00

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.