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 issuesâbilingual 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.
BS in Engineering.
0â5 years of experience in medical device, clinical, or related 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) â required for cross-site and supplier communication.
Experience with change control and supplier quality processes.
General knowledge of GMP and quality system requirements.
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