Azenta Inc-posted about 1 month ago
$63,000 - $79,000/Yr
Full-time • Mid Level
Onsite • Indianapolis, IN
1,001-5,000 employees
Ambulatory Health Care Services

The Quality Engineer will provide investigative support in the investigation and/or correction of a nonconformance which result in attaining quality goals and GxP requirements globally. Their primary responsibility lies in promptly responding to quality issues reported within the Quality Management System, swiftly resolving them to mitigate any impact on the customer. Within a team environment, they actively contribute to the development and implementation of best practices focused on nonconformance prevention. Operating mostly independently with minimal supervision, their work undergoes review at cross-functional team meetings. Alongside the extended team, they lead the management of CAPA processes, aiming to provide solutions and prevent recurrence, with the overarching objective of achieving Customer Zero defects.

  • Complaint Handling and Resolution: Receive, document, and investigate customer complaints promptly and thoroughly.
  • Investigates, interviews, and documents findings in the QMS to include identification of appropriate root cause and corrective actions while satisfying established due dates and ensuring timely closure.
  • Ensures that all nonconformities are investigated, documented, and resolved appropriately.
  • Proposes and initiates effective corrective action(s) to eliminate root cause reoccurrence.
  • Attends meetings as required such as in-service meetings, committee meetings, department meetings, etc.
  • Work with internal and external stakeholders to resolve quality issues that arise as quickly and efficiently as possible to prevent compromising quality and safety standards.
  • Monitor and update Quality Dashboard and key performance indicators.
  • Promote the use of customer preferred techniques for continuous improvement such as 8D Problem Solving Methodology, 5 Whys etc
  • Four-year degree in Life Science/Engineering or equivalent work experience.
  • Four years' experience in corrective action management, including driving actions to completion.
  • Experience in a life sciences environment
  • 1 year minimum of Azenta experience.
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