Quality Engineer

We are looking for a hands-on Quality Engineer to support a Class III medical device manufacturing environment. This role will work closely with production, manufacturing engineering, and operations teams to identify quality issues, investigate nonconformances, drive CAPA activities, and improve manufacturing quality processes on the production floor.

Key Responsibilities:

• Provide daily quality engineering support on the manufacturing floor
• Investigate nonconformances, defects, scrap, and rework issues
• Lead root cause analysis using tools like 5 Whys and Fishbone
• Support CAPA, deviation investigations, and containment activities
• Review production and inspection data to identify trends and improvement opportunities
• Ensure compliance with FDA regulations, ISO 13485, and GMP requirements
• Partner cross-functionally with operators, supervisors, manufacturing engineers, and quality teams
• Drive continuous improvement initiatives to improve yield and reduce defects

Required Qualifications:

• Bachelor’s degree in Engineering, Quality, Manufacturing, Biomedical, Mechanical Engineering, or related field
• Experience in medical device or regulated manufacturing environments
• Knowledge of CAPA, NCRs, root cause analysis, and production quality support
• Familiarity with FDA regulations and ISO 13485
• Strong problem-solving and communication skills
• Comfortable working extensively on the production floor

Preferred Experience:

• Class II or Class III medical device manufacturing
• In-process inspection and manufacturing controls
• Continuous improvement and defect prevention initiatives