Description

Own production line transfers, test method validation, and quality system compliance for manufacturing operations.

This role is on-site.

Responsibilities

• Support production line transfers, including creation of PFMEA and leading component qualification activities.
• Develop, validate, and maintain test methods while ensuring compliance with FDA/GMP guidelines and internal quality policies.
• Conduct failure analysis and investigate manufacturing issues during process development.
• Assure documentation and procedures are created, updated, and maintained as required.
• Integrate into cross-functional teams to provide creative solutions for project quality needs.

Required Skills

• BS or BA in chemical, biochemical, mechanical, electrical, Industrial Engineering, Biological Sciences, Chemistry, or related field.
• Minimum 2 years of experience in quality engineering or manufacturing.
• Working understanding of Quality Systems Regulations, including Good Manufacturing Practices (GMP), ISO, and FDA requirements.
• Proficiency in Microsoft programs.
• Working knowledge of statistical methods and statistical application software.
• Ability to work independently and in teams with minimal supervision.

Preferred Skills

• Professional certification (CQA, CQE, SQE, CQM, Six Sigma, etc.).
• Project management experience.

Key Skills

Education

Bachelor's degree