Quality Engineer

Meriden Media; Nottingham; On-site; GBP 42,000; Full time

Job summary

An established industry player is looking for a Quality Engineer to enhance quality processes and ensure compliance with industry standards. This role requires collaboration with Operations, Manufacturing, R&D, and Quality teams to drive continuous improvement initiatives. You will lead investigations into market defects, implement corrective actions, and ensure that manufacturing processes adhere to operational and regulatory requirements. If you have a strong background in quality operations within biotech or pharmaceutical manufacturing and possess excellent problem-solving skills, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• 5+ years of experience in quality operations in biotech or pharmaceutical fields.
• Strong knowledge of ISO 9001/13485 and regulatory compliance.

Responsibilities

• Lead quality investigations for market defects and implement corrective actions.
• Collaborate with teams on failure modes and drive process improvements.

Skills

Problem-solving

Communication

Collaboration

Decision-making

Education

Degree in Business

Degree in Sciences

Degree in Engineering

Tools

ASQ

Lean Six Sigma

MS Office

Job description

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.