Supplier Quality Engineer II

Medial Group; Villalba (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Medial Group is seeking a Supplier Quality professional in Villalba, Puerto Rico. The role focuses on qualifying suppliers, ensuring GMP and quality standards, and coordinating with NPD for quality parts and processes.

The candidate should have at least 3 years in a regulated industry, a Bachelor in Engineering, and be bilingual. On-site work in Villalba is required, with duties spanning supplier audits, test method validation, and continuous improvement initiatives.

Qualifications

• Minimum 3 years of relevant experience in the regulated industry.
• Bachelor Degree in Engineering Completed.
• Bilingual (English/Spanish).
• Willing to work 100% on-site in Villalba, Puerto Rico.

Responsibilities

• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers per standards and may administer a Certified Supplier Program.
• Monitors supplier parts from acquisition through manufacturing cycle.
• Audits designated suppliers regularly to ensure GMP and quality standards.

Skills

Supplier Quality

Quality Assurance

GMP Compliance

Regulatory Knowledge

Education

Bachelor Degree in Engineering

Tools

Test Method Validation

NPD Collaboration

Job description

Villalba, Puerto Rico | Posted on 04/01/2025

• Ensures that suppliers deliver quality parts, materials, and services.
  
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
  
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
  
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the Company to provide customers with the highest quality and reliable products.
  
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
  
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
  
• Define Receiving Inspection requirements as required and associated test method validation for all internal Company's Test Methods.
  

*Other duties may be assigned.*

Requirements

Minimum 3 years of relevant experience in the regulated industry. Bachelor Degree in Engineering Completed. Bilingual. Willing to work 100% on-site in Villalba.