Quality Analyst II

Katalyst Healthcares & Life Sciences - Brea, CA

Full-time - Entry Level

Brea, CA

Ambulatory Health Care Services

About the position

The Quality Analyst II position is a contract role focused on independently planning, coordinating, and reporting on product quality programs. The role involves utilizing techniques in experiment design and data analysis to support sound technical decisions, generating complex data for quality reports, and managing customer feedback and complaint investigations.

Responsibilities

• Independently plan, coordinate, and report on product quality programs.
• Generate, prepare, and issue complex data for assigned quality reports.
• Coordinate complaint management activities and customer feedback failure investigations.
• Review, implement, or revise product, project, and program quality activities.
• Recommend appropriate field actions to product regulatory committees.
• Recommend appropriate product stop shipment actions to QA management.
• Recommend issues for CAPA investigation as appropriate.
• Initiate, recommend, and provide training for QA personnel.

Requirements

• Bachelor's degree (preferably in a science field).
• At least 2 years of related experience, preferably in complaint handling in a regulated environment.
• Ability to collaborate with cross-functional subject matter experts for product investigations.
• Ability to calculate and report on metrics on a daily, weekly, and monthly basis.
• Sense of ownership of a process.
• Strong teamwork and collaboration skills, with the ability to work independently.
• Ability to adapt to changing processes.
• Ability to write and edit Quality Systems documentation.