Description

You will independently plan, coordinate, and report on product quality programs using experiment design and data analysis techniques.

Responsibilities

• Plan and coordinate product quality programs to support technical decision-making.
• Generate, prepare, and issue complex data for assigned quality reports.
• Coordinate complaint management activities and customer feedback failure investigations.
• Recommend field actions, stop shipment actions, and CAPA investigations to management and regulatory committees.
• Review, implement, or revise product, project, and program quality activities.

Required Skills

• Bachelor's degree in a science field.
• 5+ years of related experience.
• Experience with QA management and CAPA.
• Ability to calculate and report on daily, weekly, and monthly metrics.
• Ability to write and edit Quality Systems documentation.
• Experience collaborating with cross-functional subject matter experts for product investigations.
• Ability to work independently and adapt to changing processes.

Preferred Skills

• Complaint handling experience in a regulated environment.

Key Skills

Education

Bachelor's Degree