Quality & Regulatory Manager — ISO 9001/13485

Azenta UK, Ltd.; Wotton; On-site; GBP 65,000 - 90,000; Full time

Job summary

Azenta UK, Ltd. is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team and deliver exceptional product standards.

You will drive continuous improvement through data-driven insights, advanced quality systems, and cross-functional collaboration to ensure regulatory compliance and customer satisfaction. Responsibilities include owning the QMS, reducing defects, and guiding the organization toward Right First Time with Lean, Six Sigma, and digital tools.

Qualifications

• 5+ years in quality leadership within manufacturing or regulated environments.
• Strong knowledge of ISO standards, QMS platforms, and data analytics tools.
• Proven ability to lead cross-functional teams and manage change effectively.
• Experience with Lean/Six Sigma methodologies and digital transformation initiatives.

Responsibilities

• Ensure a safe, compliant workplace aligned with Health, Safety, Environmental, and regulatory standards.
• Own and evolve the site’s Quality Management System (QMS) to maintain ISO9001:2015 & ISO13485 certifications.
• Lead initiatives to reduce defects and customer complaints through root cause analysis and predictive analytics.
• Partner with operations and engineering to embed ‘Right First Time’ principles and digital quality tools.
• Drive continuous improvement using Lean, Six Sigma, and automation to optimize processes.
• Oversee audits, compliance programs, and corrective actions with rigor and transparency.
• Coach and develop team members, fostering accountability, innovation, and collaboration.

Skills

Quality leadership

ISO standards

QMS platforms

Data analytics

Lean / Six Sigma

Tools

ERP

QMS tools

Data analytics platforms

Job description

Azenta UK, Ltd. is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team and deliver exceptional product standards.

You will drive continuous improvement through data-driven insights, advanced quality systems, and cross-functional collaboration to ensure regulatory compliance and customer satisfaction. Responsibilities include owning the QMS, reducing defects, and guiding the organization toward Right First Time with Lean, Six Sigma, and digital tools.