Quality Engineer

Job Summary

Seeking a highly motivated Quality Engineer, the full-time position will provide oversight for manufacturing processes, equipment qualification, and product life cycle management within a regulated cGMP manufacturing facility.

Key Responsibilities:

• Lead and support technical deviation investigations, non-conformances, and out-of-specification results while conducting root cause analyses
• Own, design, and manage Corrective and Preventive Action (CAPA) plans, ensuring effective implementation and rigorous effectiveness checks
• Review and approve engineering and process change controls to maintain the validated state of manufacturing equipment and systems

Required Qualifications:

• Bachelor of Science (BS) degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, or a related field
• 3-10 years of direct Quality Engineering experience in a cGMP commercial pharmaceutical or biotechnology manufacturing environment
• Strong working knowledge of statistical analysis, process control tools, and data integrity principles
• Expertise in root cause analysis tools such as 5-Whys and Fishbone diagrams
• Exceptional technical writing capabilities and the ability to communicate complex quality issues clearly