The Quality Assurance Associate will be instrumental in maintaining and improving the Quality management System at multiple manufacturing sites. Support of Azenta’s quality management system in accordance with FDA Quality System Regulation
The Quality Assurance Associate will be responsible for overseeing internal audits, hosting customer audits, and assisting the Quality Manager with conducting certification body audits to ensure compliance with ISO 9001 and ISO 13485 standards. The QA Associate will also gatekeep the document control function at the Wotton site. This role involves working independently while collaborating with a team for guidance.
Document ControlAct as gate keeper for the document control process.
Ensure training on new and updated processes are completed on time.
Create and progress document related change controls as needed.
Internal AuditsConduct regular internal audits at both manufacturing locations.
Evaluate processes, procedures, and documentation to ensure compliance with quality standards.
Identify areas for improvement and recommend corrective actions.
Customer Audits:Host customer audits as required.
Coordinate with cross-functional teams to provide necessary information and address any findings.
Maintain positive relationships with customers during the audit process.
Certification Body Audits:Prepare for and participate in certification body audits.
Ensure compliance with ISO 9001 and ISO 13485 requirements.
Collaborate with relevant departments to address any non-conformities.
Quality Monitoring and Reporting:Assist QA with the monitoring of quality indicators and trends.
Report findings to senior leadership.
Identify training needs and deficiencies related to quality.
Communication and Collaboration:Communicate effectively with senior leadership, colleagues, and global teams.
Collaborate with other departments (Engineering, Manufacturing, etc.) to maintain quality standards.
