Quality Assurance & Doc Control

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer‑focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships. All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity.

Working closely with Quality teams, this role as Quality Assurance and Document Control 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.

• Internal Audits: Conduct 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: Monitor 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.

• Excellent oral and written communication skills.
• Experience with document control and change control.
• Experience in batch release / product release processes.
• Familiarity with Microsoft Office applications, business mathematics, and database tools.
• Understanding of inspection and audit methods.
• Knowledge of ISO 14971 risk management for medical devices, 62304 medical device software, GxP, GMP, FEMA, NACCP and related medical device and pharmaceutical standards and regulations.

• Bachelor’s or Associate Degree in Education, Life Science, Science, Chemistry, Business, Engineering, or related field.
• Obtain and maintain a Lead Auditor Certification pursuant to ISO 19011 or equivalent.
• Minimum Requirements: Bachelor’s Science Degree with experience in Life Sciences, Medical Devices, or other highly related fields.
• Two years of experience in quality assurance or related field with a working knowledge of Change Control, Document Control, understanding of 8D corrective action methodology.
• Ability to understand complex documents related to life sciences and medical device design and manufacture such as Quality Manual (QM), Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Post Market Surveillance (PMS), Instructions For Use (IFUs), Periodic Safety Update Report (PSUR), etc.
• Organizational and small project management skills; ability to manage multiple projects and meet deadlines; utilize modern task tracking techniques.
• Proficiency in working with the Windows platform and Microsoft Office programs including Microsoft Teams, Excel, Visio; related apps such as Planner/ MS Do/Tasks or equivalents.
• Strong teamwork skills and ability to facilitate successful presentations and training programs to individuals and/or large groups at all levels of the organization.