Onsite QA & Compliance Auditor - ISO 9001/13485 Specialist

Azenta Life Sciences; Wotton; On-site; GBP 32,000 - 52,000; Full time

Job summary

Azenta Life Sciences is seeking a Quality Assurance Associate to maintain and improve the Quality Management System across manufacturing sites, with responsibility for document control, audits, and regulatory compliance on site in Wotton.

The role requires collaborating with cross-functional teams, hosting customer audits, and supporting certification body audits to ensure ISO 9001 and ISO 13485 standards are met.

Qualifications

• Bachelor or Associate Degree in Life Science, Chemistry, Engineering or related field.
• Internal Auditor experience preferred; Lead Auditor Certification desirable.
• 2+ years in quality assurance with Change Control and Document Control knowledge.

Responsibilities

• Act as gate keeper for the document control process and ensure timely training.
• Conduct internal audits and host customer audits across sites.
• Prepare for and participate in certification body audits for ISO 9001/13485.
• Monitor quality indicators, report findings, and drive corrective actions.
• Collaborate with Engineering, Manufacturing and other functions to maintain quality.
• Support training and process improvements to address non-conformities.

Skills

Internal Auditor

Quality Assurance

Change Control

Document Control

8D Methodology

Lead Auditor

Team Collaboration

MS Office

Project Management

Training Delivery

Education

Bachelor or Associate Degree

Life Science / Chemistry / Engineering

Tools

Microsoft Teams

Excel

Visio

Planner

Microsoft To Do

Job description

Azenta Life Sciences is seeking a Quality Assurance Associate to maintain and improve the Quality Management System across manufacturing sites, with responsibility for document control, audits, and regulatory compliance on site in Wotton.

The role requires collaborating with cross-functional teams, hosting customer audits, and supporting certification body audits to ensure ISO 9001 and ISO 13485 standards are met.