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.
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