Supplier Quality Engineer I

Medial Group; Ponce (PR); Presencial; USD 55 000 - 75 000; Tempo integral

Resumo da oferta

Medial Group in Ponce, Puerto Rico is seeking a quality inspector/engineer to implement and maintain incoming inspection plans, sampling plans, and acceptance activities at the Ponce site. You will evaluate inspection methods, collaborate with suppliers and COE, monitor components through manufacturing, and contribute to control plans for new products.

Bilingual English/Spanish and GD&T understanding are preferred; on-site work is required.

Qualificações

• BS in Engineering.
• 0–5 years in medical device or regulated environment.
• 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 communication.

Responsabilidades

• 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 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.

Conhecimentos

Statistics

Sampling plans

Incoming inspection

Inspection planning

GD&T basics

Bilingual

Formação académica

BS in Engineering

Descrição da oferta de emprego

Ponce, Puerto Rico | Posted on 11/14/2025

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.

*Willing to work 100% on-Site in Ponce,PR.*