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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.
