Senior Quality Engineer

Responsibilities

• Works cross-functionally in the development and/or maintenance of products or services.
• Resolves equipment and process-related production issues.
• Engages in equipment, process, material, and method validation.
• Conducts statistical analysis and metrics to evaluate systems and processes.
• Supports project work of intermediate scope and complexity without direct supervision.
• Acts as a mentor to less experienced team members.
• Applies regulatory requirements (cGMP, FDA, ISO, etc.) to support work.
• Writes test protocols, conducts tests, collects data, and prepares reports for validation.
• Provides guidance and support to colleagues with less experience.

Qualifications

• Demonstrates intermediate knowledge of quality engineering policies, principles, and best practices.
• Demonstrates intermediate knowledge of FDA/ISO requirements.
• Applies statistical sample size calculations for quality determination on projects of intermediate scope/complexity.
• Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work.
• Has in-depth experience, knowledge, and skills in own job family.
• Works independently with minimal guidance and determines own work priorities.
• Acts as a resource for colleagues with less experience.