Quality Assurance Associate

Azenta · Wotton, UK

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Role summary

Azenta seeks a Quality Assurance Associate to support and enhance the quality management system across manufacturing sites in compliance with FDA regulations and ISO standards. The role encompasses document control oversight, internal and customer audits, and collaboration with cross-functional teams to maintain compliance and drive continuous improvement.

What they're looking for

Bachelor's or Associate degree in Life Science, Science, Chemistry, Business, Engineering, or related field
Two years of quality assurance or related experience with Change Control and Document Control knowledge
Understanding of 8D corrective action methodology and nonconforming output resolution processes
Internal auditor experience preferred; Lead Auditor Certification required or expected to obtain
Proficiency with Windows, Microsoft Office, Teams, Excel, and project tracking tools
Ability to interpret life sciences and medical device documentation (QM, DHF, DMR, DHR, etc.)
Strong organizational and small project management skills with ability to manage multiple priorities

What you'll be doing

Manage document control gatekeeping function and coordinate training on updated processes
Conduct regular internal audits at manufacturing locations to evaluate compliance with quality standards
Host customer audits and coordinate cross-functional team support to address audit findings
Prepare for and participate in certification body audits to ensure ISO 9001 and ISO 13485 compliance
Monitor quality indicators, report trends to leadership, and identify training needs

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Date posted2 days ago

Last source check1 day ago

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