Quality Assurance Associate

Azenta LTD; Dorking; In loco; GBP 32.000 - 52.000; Tempo pieno

Descrizione del lavoro

Azenta UK, Ltd. seeks a Quality Assurance Associate to maintain and improve the Quality Management System across manufacturing sites in the UK. You will oversee internal audits, host customer audits, and support certification body audits to ensure ISO 9001 and ISO 13485 compliance.

Gatekeeping document control at the Wotton site is a key responsibility. The role requires collaboration with cross-functional teams, ensuring on-time training, and continuous quality improvements.

Competenze

• Bachelor's or Associate Degree in Life Science, Chemistry, Engineering or related field.
• Internal Auditor experience preferred, Lead Auditor certification desirable.
• Strong understanding of Change Control, Document Control and 8D methodology.

Mansioni

• Gatekeep the document control process and ensure training on new/updated processes is completed on time.
• Conduct regular internal audits of manufacturing processes and documentation for compliance.
• Host customer audits and coordinate with cross-functional teams to address findings.
• Prepare for and participate in Certification Body audits and ISO 9001/13485 requirements.
• Monitor quality indicators and report trends to senior leadership.

Conoscenze

Internal Auditor

Lead Auditor

Document Control

Change Control

8D methodology

ISO 9001/13485

Audit coordination

Formazione

Bachelor's or Associate Degree in Life Science or related field

Strumenti

Windows

Microsoft Office (Teams, Excel, Visio)

Planner / MS To-Do

Descrizione del lavoro

Azenta UK, Ltd.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 we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity

Job TitleQuality Assurance AssociateJob Description

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 RegulationThe 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 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 Audits Conduct regular internal audits at both manufacturing 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

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 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 techniquesProficiency 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.

This position is based fully onsite in Wotton, Surrey

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

UK - Wotton
Type: Full time