Quality Engineer

Location: Tempe, AZ • Duration: 5 months • Hours: 40/week • Pay rate: $20–25/hr • 1st shift • Contract on W2 (US citizens or Green Card holders only)

About the role

Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers, and other cGMP activities for assigned product lines in the instrument plant. Ensures documentation and procedures comply with internal Quality Policies and related FDA/GMP guidelines. Conducts complaint investigations, assists in manufacturing-issue investigations, and provides data and input on technical issues and projects.

Requirements

• BS or BA in Mechanical, Electrical, Industrial, or Biomedical Engineering, Biological Sciences, Chemistry, Computer Science, or related field (up to 2 years of experience) OR MS in same fields (no experience required)
• Working understanding of Quality Systems Regulations (GMP, ISO, FDA)
• Proven ability to develop solutions to problems of moderate scope and complexity using established policies and procedures
• Proficiency in Microsoft programs; ability to learn other systems
• Experience with TRACKWISE software is an advantage
• Strong verbal and written communication skills
• Ability to work both in teams and independently with minimal supervision
• Self-motivated, organized, detail-oriented, and capable of multitasking multiple projects