Staff Quality Engineer

Job Description

Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the CAPA, Device History Record issues, Labeling, Continuous Process Improvement Process and process-related production issues, activities including equipment, process, materials, and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

Qualifications

• Demonstrates intermediate knowledge of quality engineering policies, principles and best practices.
• Demonstrates intermediate knowledge of FDA/ISO requirements.
• Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity.
• May act as mentor to less experienced team members.
• Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision.
• Writes test protocol, tests, investigations, nonconformance reports, collects data, and writes reports to validate against plan to ensure product is used as intended.
• Has in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations
• Works independently with minimal guidance Usually determines own work priorities
• Acts as a resource for colleagues with less experience.

Benefits

Position is hybrid i.e., preferable to be on site for some period in San Diego.