Regulated Manufacturing Lead: Lean, Six Sigma & ISO 13485

Aurora Life Sciences; Leeds; On-site; GBP 55,000 - 75,000; Full time

Job summary

Aurora Life Sciences in Leeds is seeking a Production Manager to own manufacturing performance in a regulated medical device environment. You will lead on safety, quality and efficiency, balancing daily delivery with long‑term improvement using Lean, Six Sigma and ISO 13485 principles.

You will partner with Engineering, Planning and Quality to resolve issues, drive continuous improvement, and develop teams while maintaining GMP standards and robust documentation.

Qualifications

• Strong background in production leadership in regulated manufacturing.
• Experience applying ISO13485, Lean and Six Sigma.
• Ability to use data to drive improvements.
• Collaborates effectively with Engineering, Planning and Quality.
• Experience investigating non-conformances and implementing CAPAs.

Responsibilities

• Lead and develop production teams with clear objectives and visible leadership.
• Coordinate production plans around demand, capacity, labour, equipment and materials.
• Use performance data to identify trends, address inefficiencies and improve output.
• Lead Lean and Six Sigma projects to reduce waste and improve flow.
• Align Engineering, Planning and Quality to resolve issues and maintain momentum.
• Ensure activities meet ISO13485, GMP, procedures and documentation.
• Investigate non-conformances, identify root causes and implement corrective actions.
• Contribute to process validation, equipment introduction and scale-up.
• Improve layouts and workflows to enhance safety and efficiency.
• Develop training plans to sustain technical competence and progression.
• Promote a culture of prompt issue raising and sustained improvements.

Skills

Production leadership

Lean Manufacturing

Six Sigma

ISO 13485

Data-driven decisions

Cross-functional collaboration

Problem solving

Job description

Aurora Life Sciences in Leeds is seeking a Production Manager to own manufacturing performance in a regulated medical device environment. You will lead on safety, quality and efficiency, balancing daily delivery with long‑term improvement using Lean, Six Sigma and ISO 13485 principles.

You will partner with Engineering, Planning and Quality to resolve issues, drive continuous improvement, and develop teams while maintaining GMP standards and robust documentation.