Quality Assurance Associate

Working closely with Quality teams, this role as 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.

What You’ll Be Doing

• Document Control

Act 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 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:

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.

What You’ll Bring

• 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.

Qualifications:

• Bachelor's or Associate Degree in Education, Life Science, Science, Chemistry, Business, Engineering, or related field.
• Internal Auditor experience preferred. Will be expected to obtain and maintain a Lead Auditor Certification.
• Two years of experience in quality assurance or related field with a working knowledge of Change Control, Document Control, understanding how nonconforming outputs are resolved using the 8D corrective action methodology (Eight Disciplines).
• 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 required; 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;

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.