Quality Engineer II

We are seeking a diligent and proactive Quality Engineer II to join our Flow Acceleration / Lean Transformation team. The primary responsibility of this role is to embed quality principles into all process improvement and flow enhancement initiatives within our medical device manufacturing operations.

This position will serve as the quality guarantor, ensuring that leaner, faster processes also deliver safe, compliant, and high-quality products.

Responsibilities may include the following and other duties may be assigned:

• Quality Integration into process improvement projects
  

• Validation & Verification (processes and equipment)
  

• Risk Management and Mitigation
  

• Data Analysis and Metrics Tracking
  

• Lean Manufacturing Concepts Implementation
  

• Documentation Development, Procedures, and Training
  

• Regulatory Compliance & Auditing
  

• Cross-Functional Team Collaboration
  

• Project Planning and Management
  

Requirements

Experience:

• Minimum 2+ years in a quality or engineering role within a regulated manufacturing environment
  

• Experience with lean manufacturing concepts and transformations
  

• Equipment and process validation experience
  

• Cost analysis experience
  

• Project management skills
  

• Strong analytical problem-solving and communication skills (English & Spanish)
  

Additional Skills (Nice to Have):

• Agile / Lean manufacturing methodology
  

• Attention to detail
  

• Continuous improvement mindset
  

Education

• Bachelor’s Degree in Industrial, Manufacturing, Mechanical, Electrical, or Chemical Engineering