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Quality Assurance Lead Auditor

4 months ago

Manchester, United Kingdom Azenta, Inc. Full time

PRIMARY RESPONSIBILITY:

Working closely with Global Quality Assurance and Global Regulatory Affairs teams theQuality Assurance Lead Auditor in England 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 21 CFR 820, ISO 13485, ISO 9001 and ISO 14971.

The Quality Assurance Lead Auditor will be responsible for overseeing internal audits, hosting customer audits, and conducting certification body audits to ensure compliance with ISO 9001 and ISO 13485 standards. This role involves working independently while collaborating with a global team for guidance.

Key Responsibilities:

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.

Qualifications:

  • Bachelor’s Science Degree with experience in Life Sciences, Medical Devices, or other highly related fields.
  • Minimum of 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 obtain and maintain a Lead Auditor Certification pursuant to ISO 19011 or equivalent.
  • Demonstrated understanding of 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

Preferred

  • Excellent oral and written communication skills.
  • Understanding of inspection and audit methods.
  • Knowledge of ISO 14971 risk management for medical devices, 62304 medical device software, GxP, GMP and related medical device and pharmaceutical standards and regulations
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