Quality Engineer

Avantor•Devens, MA

4d•Onsite

About The Position

Avantor is looking for a dedicated Quality Engineer to optimize the Avantor Fluid Handling organization. This role is full-time and on-site in Devens, MA. The Quality Engineer will develop and maintain quality systems, inspection protocols, and testing procedures to ensure product and equipment performance. Responsibilities include analyzing quality processes, conducting testing and statistical evaluations, identifying product quality risks, and driving continuous improvements to ensure compliance, reliability, and operational excellence. The role involves using Quality Engineering principles, tools, and techniques to develop and optimize systems and processes aligned with company strategy and regulatory requirements. Support for customer, regulatory, and internal audits is also a key part of the role, as is performing investigations using root cause analysis and risk assessment tools to determine appropriate corrective actions.

Requirements

Bachelor’s degree in a natural/life science discipline with knowledge and experience in one of the following areas; Chemistry, Biology, Microbiology or cell culture; or an equivalent combination of education, certification and experience
3-5 years relevant experience
Experience in deviation and complaint investigations, including root cause analysis tools and technical writing
Experience conducting and supporting audits
Proficient in MS Office (Word, Excel, Access)
Excellent written and oral communication skills
Able to interface effectively with all levels of employees
Detailed oriented, with strong organizational skills
Ability to multi-task, prioritize work load and work independently to meet commitments with minimal supervision

Nice To Haves

CQE/CQA certification preferred

Responsibilities

Develop and maintain quality systems, inspection protocols, and testing procedures to ensure product and equipment performance.
Analyze quality processes, conduct testing and statistical evaluations, identify product quality risks, and drive continuous improvements to ensure compliance, reliability, and operational excellence.
Use Quality Engineering principles, tools and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements.
Provide support for customer, regulatory and internal audits.
Use root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action.
Lead, coordinate and maintain validations for all departments.
Lead, coordinate and maintain Calibration Program.
Lead, coordinate and maintain Environmental Monitoring Program.
Conduct audits (both internal and supplier) and monitor compliance with ISO and FDA Quality System Regulation standards.
Collect, review, and interpret data for trend report, metrics, quality system review and complaints.
Update approved supplier index as required.
Review and approve quality assurance procedures and reports.
Maintain SOPs and Quality Management System as directed by QA Manager.
Performs other duties as assigned.