Quality Engineer III

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Responsibilities: We are seeking an experienced Quality Engineer to join our team in Worcester, MA, supporting pharmaceutical, biologics, medical device, and combination product manufacturing operations. The Quality Engineer will be responsible for ensuring compliance with FDA and international regulatory standards across all stages of production-from raw material inspection through final product release. The ideal candidate will have 5-8 years of experience in QA/QC within pharmaceutical or biologics manufacturing, with a strong background in document review, process validation, and regulatory compliance. Provide quality assurance support for manufacturing processes including pharmaceuticals, biologics, medical devices, and combination products. Ensure compliance with FDA, EMA, Anvisa, and other global regulatory bodies. Review and approve batch records, manufacturing documentation, and validation reports. Support process qualification (PPQ) activities including process and raw material controls. Apply effective quality systems and procedures within cross-functional teams including R&D, MS&T, Supply Chain, and Regulatory Affairs. Participate in regulatory and internal audits; prepare and present quality data as needed. Support design control, new product introductions, and design changes to existing products. Coordinate training, continuous improvement initiatives, and quality system improvements across departments. Collaborate with suppliers and internal stakeholders for best practices and system compliance. Oversee the implementation of quality education and training programs. Requirements: Bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Biomedical Engineering, Pharmaceutical Sciences). 5-8 years of experience in Quality Assurance/Quality Engineering roles in pharmaceuticals, biologics, or medical device industries. Strong experience with. Document review. Batch record review. Process validation. Equipment validation. Manufacturing & QC document reviews. Hands-on shop-floor QA activities experience. Experience supporting GMP manufacturing environments. Experience with quality systems such as Veeva and Track Wise. Prior experience in small molecule or biologics manufacturing.
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Location:
Worcester, MA, United States
Category:
Architecture And Engineering Occupations

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