Quality Engineer

Quality Engineer

Location: South Carolina, USA

Start Date: ASAP

Experience Level: 6 months – 2 years

Employment Type: 1-Year Contract (40 hours/week)

Overview

Our client, a growing manufacturing organization, is seeking a motivated Quality Engineer to support product and process quality initiatives. This position involves working cross-functionally with production and engineering teams to identify, investigate, and resolve process-related issues while ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Collaborate with production and engineering teams to identify systematic or recurring production issues
• Conduct root cause analysis using tools such as Fishbone (Ishikawa) diagrams and structured problem-solving methods
• Investigate non-conformities and document findings (SAP training provided)
• Perform data analysis using Excel and/or Minitab to identify trends and support decision-making
• Develop and execute test protocols, collect data, and generate validation reports
• Support validation activities related to equipment, processes, materials, and methods
• Present findings and recommendations to cross-functional teams and leadership
• Participate in production floor investigations (PPE required; no machine operation involved)
• Ensure compliance with cGMP, FDA, and ISO standards under supervision

Required Skills & Qualifications

• Master’s degree
• 6 months to 2 years of relevant experience
• Understanding of quality engineering principles
• Regulatory standards (FDA, ISO, cGMP)
• Statistical analysis and sampling methods
• Data analysis (Excel required; Minitab preferred)
• Root cause analysis tools
• Strong communication skills with the ability to present findings in group settings

Preferred Qualifications

• Familiarity with SAP (especially non-conformance tracking)
• Exposure to manufacturing or regulated industries (medical devices preferred)
• Understanding of process flow and material movement in production environments