Quality Engineer at Azenta Life Sciences in Plainfield, Indiana

Job Description:

Company Overview



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.


Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.



How You'll Add Value...



The Quality Engineer will engage in direct collaboration with Operations Leaders, Regulatory Compliance, Continuous Improvement, Quality Assurance, and external stakeholders to effectively address customer complaints and ensure their resolution in alignment with relevant standards. 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.



What You'll Do...

• Complaint Handling and Resolution Receive, document, and investigate customer complaints promptly and thoroughly.


• Manage all Customer impacted quality related issues NCs/CAPAs external and internal raised within the Quality Management System Database.


• Triage NCs based on Risk Management.


• Identify root cause and instigate permanent corrective actions for quality issues raised.


• 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.


• Spearhead and engage in cross-functional teams dedicated to implementing Corrective Actions to address customer-facing issues, steering teams through root cause analysis and problem resolution processes.


• Promptly receive, document, and thoroughly investigate customer complaints.


• Conduct root cause analysis to identify underlying issues leading to complaints.


• Develop timely and effective solutions to address customer concerns.


• Monitor and evaluate product/service quality based on customer feedback and complaint data.


• Proactively identify trends and recurring issues to address quality concerns.


• Collaborate with relevant departments to implement quality improvement initiatives.

• 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.


• Work effectively in diverse and dynamic environments.


• Plan and prioritize activities to meet quality objectives.


• Demonstrate strong communication and interpersonal skills.


• Effectively present data to stakeholders.


• Possess analytical skills to interpret quality data and drive improvements.

• Employee will be working in an area with potentially infectious materials. Employee will be responsible for maintaining a clean work environment while enforcing and following universal precautions for blood borne pathogens when working in an area considered to be potentially contaminated.


• Some travel, including international travel may be required.


• Position will be Fully On-site (Indianapolis/Plainfield)