Quality & Regulatory Lead - ISO & Lean Transformation

Azenta Life Sciences; Wotton; On-site; GBP 90,000 - 110,000; Full time

Job summary

Azenta Life Sciences is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team onsite in Wotton, Surrey. You will drive regulatory and quality compliance, maintain ISO9001:2015 and ISO13485 certifications, and champion continuous improvement across functions.

The role focuses on reducing defects, leveraging data analytics, digital quality tools, and Lean Six Sigma to deliver superior product quality and customer satisfaction in a fast-paced, global environment.

Qualifications

• 5+ years in quality leadership within manufacturing or regulated environments.
• Strong knowledge of ISO standards and QMS platforms.
• 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 and readiness for future standards.
• Lead initiatives to reduce defects and customer complaints through root cause analysis, predictive analytics, and proactive prevention strategies.
• 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 and enhance customer experience.
• Oversee audits, compliance programs, and corrective actions with rigor and transparency.
• Coach and develop team members, fostering a culture of accountability, innovation, and collaboration.

Skills

Quality leadership

Cross-functional leadership

ISO standards

Lean Six Sigma

Digital transformation

Tools

ERP systems

QMS platforms

Data analytics

Job description

Azenta Life Sciences is seeking a C&I Quality & Regulatory Manager to lead a high-performing quality team onsite in Wotton, Surrey. You will drive regulatory and quality compliance, maintain ISO9001:2015 and ISO13485 certifications, and champion continuous improvement across functions.

The role focuses on reducing defects, leveraging data analytics, digital quality tools, and Lean Six Sigma to deliver superior product quality and customer satisfaction in a fast-paced, global environment.