Quality Engineer

TN United Kingdom; Nottingham; On-site; GBP 42,000; Full time

Job summary

An established industry player is seeking a Quality Engineer to enhance quality processes and ensure compliance with industry standards. This role involves collaborating with various teams to drive continuous improvement and manage quality investigations. You will lead efforts to identify root causes of defects and implement corrective actions, while also ensuring that manufacturing processes adhere to operational and regulatory requirements. The ideal candidate will possess strong problem-solving and communication skills, with a solid background in quality operations within biotech or pharmaceutical sectors. If you are passionate about quality and compliance, this opportunity is perfect for you.

Qualifications

• 5+ years’ experience in quality operations within biotech or pharmaceutical manufacturing.
• Strong knowledge of ISO standards and regulatory compliance.

Responsibilities

• Lead quality investigations for market defects and implement CAPA.
• Drive process improvement initiatives using SPC, Six Sigma, and Lean.

Skills

Problem-solving

Communication

Collaboration

Decision-making

Education

Degree in Business

Degree in Sciences

Degree in Engineering

Tools

SPC

Six Sigma

Lean methodologies

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.

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