Supplier Quality Engineer I

• Implement and maintain incoming inspection plans, sampling plans, and acceptance activities for the Ponce site.
  

• Evaluate and define proper inspection methods, measurement techniques, and acceptance criteria.
  

• Collaborate with suppliers, Ponce site teams, and Company's COE to resolve supplier-related issues—bilingual communication required.
  

• Monitor supplier components from acquisition through manufacturing, ensuring compliance with GMP, quality standards, and industry regulations.
  

• Assess supplier performance through audits, evaluations, and feedback; support Certified Supplier Program activities.
  

• Define Receiving Inspection requirements and support test method validations.
  

• Support Pre-Market Supplier Quality activities as needed, collaborating with Component Engineering and NPD teams.
  

• Develop inspection plans, product acceptance strategies, and contribute to Control Plans for new products.
  

• Other duties may be assigned.
  

Requirements

Education & Experience

• BS in Engineering.
  

• 0–5 years of experience in medical device, clinical, or related regulated environment.
  

Must Have

• Basic knowledge of statistics, sampling plans, and incoming inspection.
  

• Ability to develop inspection plans and define acceptance strategies.
  

• Understanding of measurement methods and basic inspection techniques.
  

• Basic understanding of GD&T (engineering drawings).
  

• Bilingual (English & Spanish) — required for cross-site and supplier communication.
  

Nice to Have

• Experience with change control and supplier quality processes.
  

• General knowledge of GMP and quality system requirements.