Biotech jobs in United States

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).

1. Lead quality investigations for market defects, identifying root causes and implementing CAPA.
2. Collaborate with cross-functional teams on failure modes and impact assessments.
3. Interface with customers and suppliers to address manufacturing non-conformances.
4. Drive process improvement initiatives using SPC, Six Sigma, and Lean methodologies.
5. Ensure manufacturing processes meet operational and regulatory requirements (ISO 9001, 13485, 21 CFR Parts 210 & 211).
6. Support audits, change control, document control, and product validation.
7. Provide training and guidance on best practices and quality standards.

1. Degree in Business, Sciences, or Engineering.
2. 5+ years experience in quality operations within biotech or pharmaceutical manufacturing.
3. Strong knowledge of ISO 9001/13485 and regulatory compliance.
4. Proficiency in problem-solving tools (ASQ, Green Belt, Lean Six Sigma preferred).
5. Excellent communication, collaboration, and decision-making skills.
6. Advanced MS Office skills preferred.

Please click to apply or call 01332 363000 opt 3, or please email your CV to