Sr Supplier Quality Engineer

Senior Supplier Quality Engineer

We’re looking for a Senior Supplier Quality Engineer (SQE II) to join a cross-functional team supporting supplier quality, manufacturing, and engineering.

This role is a great fit for someone who enjoys hands-on problem solving, supplier development, corrective actions, and working closely with engineering and operations teams in a regulated manufacturing environment.

Key Responsibilities

• Partner with Engineering, Operations, and Supplier Quality teams to investigate and resolve supplier-related issues
• Lead and support Corrective and Preventive Actions (CAPA) and nonconformance investigations
• Support supplier development and performance improvement initiatives
• Monitor supplier quality from component acquisition through the manufacturing process
• Participate in supplier audits and assessments to ensure GMP and quality standards are met
• Evaluate supplier processes and provide feedback to improve quality and performance
• Support quality system compliance, including change control, deviations, and nonconformances
  
  

Required Qualifications

• Bachelor’s degree with 4 years of relevant experience, or an advanced degree with 2 years of relevant experience
• Experience with CAPA, nonconformance, change control, deviations, and GMP
• Experience using TrackWise or a similar QMS
• Hands-on product problem-solving experience
• Technical engineering background in Mechanical, Industrial, Operations, Biomedical Engineering, or a related field
• Experience working in a regulated manufacturing environment
  
  

Preferred

• Lean Six Sigma Yellow Belt certification
• Green Belt certification
• Supplier auditing or supplier development experience
  
  

DR2