Quality Engineer

The Opportunity

Avantor, a Global Fortune 500 company is looking for a dedicated Quality Engineer to optimize our Avantor Fluid Handling organization. This Devens, MA based role is full-time, on-site.

What We're Looking For

• Education: 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
• 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
• Collaboration Tool: Must be proficient in MS Office (Word, Excel, Access)
• Preferred Qualifications:
  • CQE/CQA certification preferred

How You Will Thrive And Create An Impact

As a Quality Engineer, you will develop and maintain quality systems, inspection protocols, and testing procedures to ensure product and equipment performance. You will 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.

Knowledge Skills And Abilities (Those Necessary To Perform The Job Competently)

• Excellent written and oral communication skills are required
• Able to interface effectively with all levels of employees
• Must be detailed oriented, with strong organizational skills, ability to multi-task, prioritize work load and work independently to meet commitments with minimal supervision

Environmental Working Conditions & Physical Effort (Under Typical Positions)

• Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
• Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
• A frequent volume of work and deadlines impose strain on routine basis.
• Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.
• Minimal travel may be required.