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Avantor Quality Engineer in Devens, Massachusetts

Job Summary The Quality Engineer works independently under close supervision to apply, and maintain quality evaluation and control systems/protocols. Implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Analyze inspection and testing processes, mechanisms, and equipment. Conduct quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks. Lead and manage the customer complaint and CAPA management systems. MAJOR JOB DUTIES AND RESPONSIBILITIES: 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. Use root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action. Lead, coordinate and maintain customer complaint & CAPA management system. Lead, coordinate and maintain validations for all departments, the Calibration Program and the 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. Provide support for customer, regulatory and internal audits. Performs other duties as assigned. QUALIFICATIONS: 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 in deviation and complaint investigations, including root cause analysis tools and technical writing required Experience conducting and supporting audits is required. CQE/CQA certification preferred KNOWLEDGE SKILLS AND ABILITIES: Minimum 3-5 years relevant experience Excellent written and oral communication skills are required Able to interface effectively with all levels of employees Must be proficient in MS Office (Word, Excel, Access) 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: 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. Some travel may be required. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

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