Quality Engineer

Salary

Core Qualifications

Preferred Qualifications

Key Responsibilities

• •Developing, applying, and maintaining quality evaluation and control systems and protocols
• •Designing and analyzing inspection and testing processes, methods, and equipment to ensure product quality and accuracy
• •Performing statistical analysis to assess process control and manage product quality risks
• •Leading or supporting root cause investigations, including nonconformances, deviations, CAPA, and audit observations
• •Supporting product lifecycle quality activities, including design, manufacturing, supplier quality, and continuous improvement initiatives
• •Using statistical tools to define sampling plans and support engineering in process and vendor specifications
• •Reviewing validation documentation (e.g., IQ, OQ, PQ, and software validation) to ensure compliance with requirements
• •Supporting software validation activities in line with applicable regulatory guidelines and throughout the validation lifecycle
• •Participating in pFMEA activities, including documentation and facilitation of risk assessments
• •Investigating nonconforming materials and supporting disposition decisions based on risk and quality standards
• •Ensuring compliance with all applicable regulations, policies, and procedures, including environmental, health, and safety requirements
• •Contributing to audit readiness and continuous improvement of the Quality Management System