Quality Assurance Lead: ISO 9001/13485 & Internal Audits

Azenta LTD; Wotton; On-site; GBP 35,000 - 65,000; Full time

Job summary

Azenta LTD is seeking a Quality Assurance Associate to maintain and improve our Quality Management System across multiple manufacturing sites in the UK. You will gatekeep document control, host audits, and support ISO 9001/13485 compliance while collaborating with cross-functional teams.

The role requires independence with team guidance, audit experience, and potential Lead Auditor certification. Strong communication and organizational skills are essential for success in this position.

Qualifications

• 2+ years of quality assurance or related field.
• Experience with Change Control and Life Sciences documentation.
• Familiarity with ISO 9001 and ISO 13485 standards.
• Lead Auditor Certification preferred.

Responsibilities

• Act as gate keeper for the document control process and ensure timely training on new/updated processes.
• Conduct regular internal audits at manufacturing locations and identify improvement opportunities.
• Host customer audits and coordinate information with cross-functional teams.
• Prepare for and participate in certification body audits to address non-conformities.
• Monitor quality indicators and report trends to senior leadership.
• Collaborate with Engineering and Manufacturing to maintain quality standards.

Skills

Internal Audits

Document Control

Cross-functional Collaboration

Training & Facilitation

Audit Hosting

Education

Bachelor's or Associate Degree

Tools

Microsoft Teams

Excel

Visio

Job description

Azenta LTD is seeking a Quality Assurance Associate to maintain and improve our Quality Management System across multiple manufacturing sites in the UK. You will gatekeep document control, host audits, and support ISO 9001/13485 compliance while collaborating with cross-functional teams.

The role requires independence with team guidance, audit experience, and potential Lead Auditor certification. Strong communication and organizational skills are essential for success in this position.