Quality Engineer III

Company : Katalyst Healthcares & Life Sciences

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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